International device safety notices

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Continuing the International device safety notices list, 1000 records per page.

1. fa065a71-8fe4-ebfe-f7db-02c8272d18b3
2. Urgent Field Safety Notice for AK 95, AK 96, AK 98, AK 200 S. AK Ultra by Gambro Lundia AB
3. Urgent Field Safety Notice for Artis, Evosys, Integra, Innova by Gambro Dasco S.p.A.
4. 8162815|8168754
5. 10568604
6. ea9bc13f-3883-4bd7-190f-3efe4cc7cf01
7. Urgent Field Safety Notice for Vanadis Core Buffer kit by Wallac Oy
8. Technical name;
9. 1f838908-db7f-d535-0b5a-d81534524c7e
10. 89ff5c66-72b5-91f7-2eec-cf89e7aae96a
11. e38dfdbf-5765-0b05-f45f-3b59f9f76ded
12. 030.0040|030.0040-1|040.0011|040.0011-1|042.0014|099.0018
13. Technical name: SURGICAL TABLES
14. ba8e5bdd-c096-ef08-efe0-7ff0c7bde37c
15. Urgent Field Safety Notice for Secura by Smith & Nephew Medical Ltd.
16. 801764
17. 995962fa-b4fb-9922-1deb-c6750bddc8ac
18. Urgent Field Safety Notice for Laguna Duschstuhl/Duschhocker by RUSSKA - Ludwig Bertram…
19. 60ddbc2d-53d3-b31d-aed7-24afa8824c72
20. Technical name: Patient Lift
21. 468a3301-dd09-a601-7755-017a3756249b
22. Urgent Field Safety Notice for cobas 8000 core unit, cobas pro sample supply unit, cobas c…
23. Xiamen Compower Medical
24. 3089235e-c7bb-93be-4faa-11479b49ce2e
25. Urgent Field Safety Notice for Sterile Einweginstrumente und Implantate by Mahe Medical…
26. Technical name: Anesthesia system
27. 703f6d22-7b7d-35ce-50bb-e37c16e27fc2
28. 488cde9f-7142-4012-fed4-a7d5659f4960
29. 2f30e54e-f4a2-cc05-68f0-938f8928211b
30. c2e6aa8b-6abb-53f7-8f81-f58cfc0d1cc5
31. 0e3432a2-9399-e937-8b04-24a89ec66c94
32. Technical name: Antibiogram test
33. bcf51e4a-5d3b-fc54-2de9-cf9e00cf535a
34. 15d5a0ee-2e70-f017-ede7-45d41700f17d
35. dd24f02d-705f-3507-5bf5-087e169efc02
36. Alert 2057 (Technosurveillance) Update - Announcement from the company Magnamed Tecnologia…
37. a98a5eab-73fb-2353-5278-5960b3b12ede
38. 50eec3b8-0a0d-3c3a-0fba-0a24db933d28
39. 404a556f-4646-afde-e0f5-0481cf939bc3
40. 69-013B
41. 12033675-6c5c-b155-c02d-81fa3069077c
42. Urgent Field Safety Notice for EcoFit Hüftpfannen zementfrei / EcoFit Hüftpfannen EPORE…
43. 5701891e-6fe1-0d62-7e48-04797561251d
44. 39757e48-b4de-1716-cc1a-ea935073a9dc
45. Short Curved Suction 90, EM
46. Alert 2058 (Technosurveillance) Update - Announcement from the company Magnamed Tecnologia…
47. ab9dabff-8ce9-fdfc-fac4-1bab20aeb7d1
48. 0598b3e0-18b2-a90a-1db8-f02d50f685e8
49. Urgent Field Safety Notice for therascreen PIK3CA RGQ PCR Kit (24) by QIAGEN GmbH
50. RT-2006|RT-2008|RT-2010|RT-2012|RT-2014|RT-2016|RT-2018|RT-2020|RT-2108|RT-2110|RT-2112|RT…
51. Technical Name: Defibrillator
52. 84d15568-c5e7-d60b-5a2f-6a78aa5d0975
53. Urgent Field Safety Notice for AXIOS, Hot AXIOS, mit Einführsystem by Boston Scientific…
54. Urgent Field Safety Notice for Philips-EPIQ and Affiniti Ultrasound system by Philips…
55. Urgent Field Safety Notice for IMMULITE/IMMULITE 1000 TNF -alfa by Siemens Healthcare…
56. CHAIRS, EXAMINATION/TREATMENT [] Electric Chairs, Disabled Patients, , Geratric…
57. Neaktivní implantabilní zdravotnické prostředky
58. Technical name: AUTOMATIC / SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR
59. 8a0a9c31-5219-a012-96e8-d51bcbe79f19
60. 4a016060-22d1-03f5-075e-15667f86634f
61. 4c4083d4-b67f-87db-9da7-af06ef880449
62. iPlan RT Image (below v.4.1.2)/ iPlan RT; and BrainSCAN
63. Technical name: ANTIBODIES/SYSTEMS FOR DIFFERENTIAL CELL COUNTING
64. 88708388-086b-acac-46fa-212e857d1937
65. 53afe06e-b383-dc13-6f3a-b1b2cd2fa642
66. c79a584b-5b9a-dbe6-a058-00933d631454
67. Urgent Field Safety Notice for Amara View Minimal Contact Full-Face Mask (Full Face Mask)…
68. 7453-X|7526-X|7905-X|9601-X|9602-X
69. Beckman Coulter Access Free T3, T4, Total T3, GI Mon, Tg, TgAbII - võimalik koosmõju…
70. Technical name: FREEZE DRIED RABBIT COMPLEMENT ABC 1ML
71. K3085
72. 168424c2-635c-2204-fabe-35910419bb7e
73. 1.007.5158
74. IMMULITE 2000 XPi
75. Technical name: HLA Typing Kit by SSO for Class I and II - Labtype
76. 267eefc5-3068-5fdf-f1f5-f68d0e31a271
77. aabbec25-7331-f0fe-f93c-1e34a3110552
78. 653f90ce-8778-2272-6e06-045c37dc2461
79. Capture-R Ready Indicator Red Cells
80. Technical name: Implantable Pulse Generator for Neurostimulation
81. c1dc0d02-8502-83fd-6165-670548e21496
82. Urgent Field Safety Notice for Humidifier Bottle and Syringe filter kit for BT37 by Planer…
83. Urgent Field Safety Notice for LinkSymphoKnee - Patella Sizing Template, Stainles by…
84. 805a6fe0-d775-5b44-7b44-83bebbb8a682
85. Technical name: ELEKTA PLANNING SYSTEM
86. 1ed00d91-d26e-5c71-20d5-bd3cdbfe6736
87. Olympus Medical Systems Corporation Thunderbeat Type – S - tagasikutsumine, tihendinupu…
88. f6b134b1-1d4c-6964-c66e-a31189cebf13
89. Urgent Field Safety Notice for EndoPredict QS Kit Uno & EndoPredict QS KIt Duo by Myriad…
90. 355f804c-5aa5-0bae-1419-56b450d87689
91. Technical name: Disposable Needles and Disposable Syringe
92. 22758249-e2f7-fd9e-c378-f863d9fbe7c9
93. Urgent Field Safety Notice for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle by…
94. Urgent Field Safety Notice for EPIONE device by Quantum Surgical
95. Urgent Field Safety Notice for BRAUN THERMOSCAN PRO 6000 by Welch Allyn Ltd
96. Urgent Field Safety Notice for BIPOLAR CUP TRIAL HEAD by Aesculap AG
97. Urgent Field Safety Notice for Optilite Freelite Kappa Free Kits by The Binding Site Group…
98. Urgent Field Safety Notice for Olympus Everest Bipolar Cutting Forceps by Gyrus ACMI Inc.
99. Technical name: TOTAL KNEE PROSTHESES
100. Urgent Field Safety Notice for Aquacel Ag Hydrofiber Dressing with silver by ConvaTec…
101. Urgent Field Safety Notice for ARTIFLEX phakic IOL, ARTIFLEX toric phakic IOL by Ophtec BV
102. 6297c0f2-6f04-2a1e-897a-89be4e6a52e4
103. 7d6d7b69-a339-2556-2828-78a81ca90001
104. 10445169|10716281
105. 8311c5f8-a77b-0e96-c484-4f3e9ff1006f
106. Urgent Field Safety Notice for HLS Kanüle PAL 1723; BO-PVL 2155; BO-PVL 2355 by Maquet…
107. 4579e5a2-91aa-46cd-0af3-d1f12839cee4
108. Technical name: Drain
109. 74270b84-1cd2-9aad-36ed-f2fd5f531285
110. d3b15455-7b60-bcb9-f40b-0acd756c8637
111. Technical name: 2901010 Planning Software.
112. f04e6be0-bb46-b9ca-be25-7893f1e8f932
113. 2000-03|5000-01-03
114. Urgent Field Safety Notice for Copeland Fetal Scalp Electrode by Rocket Medical plc
115. VITEK 2 Piperacillin/Tazobactam Test
116. Clinac Linear Accelerator
117. CHAIRS, EXAMINATION/TREATMENT [] Electric Chairs, Disabled Patients, , Geratric…
118. Zdravotnické prostředky pro jednorázové použití
119. Technical name: Etest COLISTINA
120. bf590783-6b66-8bdf-04a7-d1465fa4232c
121. b2ac4471-4576-e4d3-7ff1-48bc771bce35
122. c2d3f0ca-4a07-41e2-3ce5-46762d25844b
123. Urgent Field Safety Notice for Arrow FiberOptix Intra-Aortic BalloonArrow Trerotola…
124. 6d239f9d-1b63-df86-9f94-3edb499dd16d
125. Technical name: Nuclisens easyMag Magnetic Silica
126. 3aaef02c-8471-aad8-b8d1-b0d7c2a879dc
127. Urgent Field Safety Notice for VENUS by HumanTech Germany GmbH
128. Urgent Field Safety Notice for Corpuls 3 by GS Elektromedizinische Geräte G. Stemple GmbH
129. Urgent Field Safety Notice for NADAL Troponin I Test by nal von minden GmbH
130. Urgent Field Safety Notice for Diverse Produkte (Kompressionsstrümpfe, Bandagen, Orthesen)…
131. 1249c050-26c3-29fd-811a-0c9d3b478c77
132. 3dc5d6e3-7231-265d-3727-42dbb17d59e3
133. 31140208|31140216|31140257|471711
134. Technical name: PROSTATIC SPECIFIC ANTIGEN (PSA)
135. 6f15b699-2767-fe9a-5788-ad2d7fc4b6a4
136. Technical name: Blood Agar
137. 7f65bc80-93a6-7c21-a29c-badc7bb945a2
138. Urgent Field Safety Notice for exoplan by exocad GmbH
139. ef1817a7-b58f-6414-dede-223647242aef
140. Technical name: AMMONIA
141. Urgent Field Safety Notice for Collection Red cell LCR filter set by MacoPharma S.A.
142. 9ee980db-c6fe-705a-c30d-0eae16ece03c
143. 2a10d1d9-17fc-33a4-0402-5e54ba90a400
144. Urgent Field Safety Notice for Vasoview Hemopro Endoscopic Vessel Harvesting Sys. by…
145. 142cedad-3178-77ef-6e5b-5d323b83ae77
146. Technical name: Positron Emission Tomography Equipment
147. Zdravotnické prostředky pro jednorázové použití
148. Urgent Field Safety Notice for Zystostom 10 Fr by Shaili Endoscopy
149. 4b6fda5e-9608-8875-e8c4-eb2a22744e82
150. 99a61020-2f6b-461e-49b4-6655ea5e30c8
151. 58f7033a-009d-e95c-4465-91f009166131
152. ed98acde-9eb1-4c16-dee0-ead1ad2e3655
153. Technical name: Angiography Equipment
154. Aktivní implantabilní zdravotnické prostředky
155. b68405a9-d7e9-4a36-d508-1227f0c7b337
156. HeartStrat MRx Defibrilator mit Q-CPR Meter option
157. Technical name: INTACT PARATHYROID HORMONE (iPTH)
158. 14f9d671-7bd3-5106-5fec-95cb4cdc3058
159. Urgent Field Safety Notice for CorVocet Biopsy System by Merit Medical Systems Inc.
160. 3890bd53-5f1d-ca24-6a7b-d125dbce789c
161. Urgent Field Safety Notice for OPTILENE SILVER MESH by B. Braun Surgical S.A.
162. 490505
163. Technical name: Software
164. Zdravotnické prostředky - nástroje pro opakované použití
165. 21b0dfc1-00d6-5e33-214c-e502acff6ebb
166. 50a84590-cd9b-38f6-e12b-8e59141dcab2
167. Technical name: Angiography Equipment
168. Zdravotnické prostředky - nástroje pro opakované použití
169. Urgent Field Safety Notice for BD Insyte Autoguard Shielded IV Catheters, BD Insyte…
170. Urgent Field Safety Notice for MiTF, (C5 & D5) by Bio S., Inc.
171. 173ee991-71d3-f2a5-5463-2c6e7673df80
172. 92b00aca-a201-28c0-bf35-856f770304d3
173. 9c0e18fa-b9b5-4bc1-04f0-c30dc79eacc9
174. 50892633-1e16-ad92-9b65-c6a201784278
175. B125P/B105P/B125M/B105M/B155M Patient Monitor
176. MOSAIQ
177. Subset of IFORIA, INTICA, IFORIA ICDs / CRT-Ds manufactured by Biotronik
178. CHAIRS, EXAMINATION/TREATMENT [] Electric Chairs, Disabled Patients, , Geratric…
179. Diagnostické zdravotnické prostředky in vitro
180. Technical name: Angiography Equipment
181. Zdravotnické prostředky v nemocničním vybavení
182. Urgent Field Safety Notice for CHC Hemo by Change Healthcare Canada Company
183. c3f32c0a-3a32-a0bb-8c73-04adb5c07f86
184. b4671bed-551a-5e3e-cd5f-ba6ea5fe22bc
185. Technical name: Angiography Equipment
186. Diagnostické zdravotnické prostředky in vitro
187. Urgent Field Safety Notice for Valgusplatte by PETER BREHM GmbH
188. e2bc33ab-b782-0451-5f2f-6d0c1087d958
189. 6e54d9e9-3c6c-f35d-dbb0-cb615f971ecf
190. Technical name: D-DIMER
191. 32fa5520-bc00-2848-3d8b-bd74d8ba7391
192. 41f5656d-683b-b699-e56b-fc66c12730eb
193. 3cdf98a5-39a3-3f4c-9f05-dd614cebdf69
194. Technical name: ANTIGEN CA 19-9
195. db94c4d9-261e-8dfe-f298-48f1fa39b9b2
196. Urgent Field Safety Notice for SafeStar Plus, TwinStar HEPA Plus by Drägerwerk AG & Co…
197. Technical name: Hematological Analyzer
198. be27154c-c8c8-e972-61e1-3ebe273df071
199. Urgent Field Safety Notice for Capio SLIM Suture Capturing Device by Boston Scientific…
200. VITROS 5600
201. Technical name: Scintigraphic Chamber;
202. 303ea3b7-3e75-76bb-d75a-fc9cae6ced02
203. Urgent Field Safety Notice for Puritan Bennett 500 Series Ventilator by Covidien llc
204. Urgent Field Safety Notice for defibrillator EMBLEM S-ICD and EMBLEM S-ICD electrode by…
205. b740eadf-ed1f-7be1-2743-fcf88447922c
206. Urgent Field Safety Notice for Silicone Resuscitator Set; for infant by VBM Medizintechnik…
207. Technical name: Magnetic Resonance Equipment
208. 3b672a86-8354-98a3-3306-cab0daa03dae
209. 0922e3e4-ff09-f872-bb28-3358a804c823
210. Urgent Field Safety Notice for 23GA Staubsauger/Extrusions Handstück stumpf by Bausch &…
211. Urgent Field Safety Notice for 25GA Staubsauger/Extrusions Handstück stumpf by Bausch &…
212. Urgent Field Safety Notice for AXS Universal Aspiration Tubing by Medela AG
213. 2c4afd64-bdd2-1cd3-b7ac-907c1b777cdf
214. Urgent Field Safety Notice for MAGEC Spinal Bracing and Distraction System by NuVasive…
215. 453e4326-2e59-6c13-9d05-914275354683
216. Urgent Field Safety Notice for G8 Elution Buffers HSi No.2 by Tosoh Corporation
217. Technical name: Computed Tomography Equipment
218. Elektromechanické zdravotnické prostředky
219. Urgent Field Safety Notice for Symbia Pro.specta by Siemens Medical Solutions USA, Inc…
220. Urgent Field Safety Notice for Neuropack S3 by Nihon Kohden Corp.
221. Urgent Field Safety Notice for LM150TD by Löwenstein Medical Technology GmbH + Co. KG
222. Technical name: EQUIPMENT FOR PREPARING SAMPLES FOR IN VITRO DIAGNOSIS;
223. Elektromechanické zdravotnické prostředky
224. Urgent Field Safety Notice for Lead Clippers by Cook Vandergrift Inc.
225. 579da947-d637-4a89-1817-aa7f09eab4f0
226. Urgent Field Safety Notice for MobileLink Acetabular Cup System by Waldemar Link GmbH &…
227. 4c843b46-4f45-5bb9-6e8e-735f77134f9d
228. PMAC71RSC - Reusable Sensor Cable for PM7100 and PMAC71RIC / Reusable Infant Sensor…
229. 45ea18f3-7cee-e109-aab5-ce5aa1c84a96
230. Technical name: MULTIPARAMETER CALIBRATORS AND STANDARDS OF ONE OR MORE CONCENTRATIONS…
231. f560416c-5b29-bfec-7ec6-c692aacc4b5c
232. 06806e35-2388-fd4c-f4d7-5660c9a2bd89
233. bc377bbf-3573-bf64-3b48-0abd3c92c86f
234. BIOPHEN ARIXTRA CONTROL PLASMA
235. BOTTLES, MEDICINES
236. Zdravotnické prostředky pro jednorázové použití
237. Technical name: Ultrasound Device
238. 8498fa19-c435-b11d-9261-8f2dd83db2c6
239. Urgent Field Safety Notice for Artis Zeego by Siemens Healthcare GmbH Advanced Therapies
240. e039fc68-ce38-572f-8790-00801b161f78
241. 59fe61d5-350d-a881-ed22-1491ddcdf6a6
242. Dental unit XO
243. bb97b132-fee3-fd8d-b397-273ee8569cdb
244. Technical name: Magnetic Resonance Equipment
245. e7f1f726-fd59-f75d-badc-47c49f511916
246. 5f79c04f-d61f-ba21-1006-e00747f1ec42
247. 1ef757a9-449a-af11-302a-e915e20c3106
248. cd52c07f-4695-54b9-9c54-9c08ff53751e
249. Technical name: ADVIA Chemistry XPT
250. 189126b3-880f-3b83-6df0-7bb854240ba1
251. db6afca7-033d-7781-037c-0e3695d6a44b
252. DTMB2D4
253. 8ffaec8f-3812-7e8d-3fb0-5a23b55ff9e6
254. Urgent Field Safety Notice for BONE SCREW Ø6,5 H.20MM - H.25MM TI6AL4V by LIMACORPORATE…
255. Technical name: Linear Accelerator
256. Zdravotnické prostředky pro diagnostiku a terapii zářením
257. ddf98661-431e-afa6-458b-f79eeea448d1
258. a0a41ca9-2053-892f-eaeb-e161052568bc
259. Technical name: IMMULITE/IMULLITE 1000 CMV IgM;
260. Neaktivní implantabilní zdravotnické prostředky
261. a200fb16-35e2-40c8-15ce-b2d64b2a30b5
262. 060ab939-5352-0c95-8bf5-53e4ae20e341
263. Urgent Field Safety Notice for Centricity High Acuity (CHA) C.C and Anesthesia by GE…
264. Technical name: REVISED IRON REAGENT - DIMENSION®
265. b3ed4ca6-2e8b-bce9-36a9-6613d2d4d76e
266. 391aa360-5c94-f843-a299-854707692b41
267. c92c2533-a709-c00c-bee1-ede9cf274f90
268. Urgent Field Safety Notice for Diverse Products with Select Lot Numbers Ending in "R" by…
269. 84e3b3d5-0172-785b-823a-52d2de53778b
270. 2745fc2a-3ba2-6710-5d76-ee088d7fa504
271. 0f751856-23fc-7888-e0b8-7f1088e8ac57
272. 29c02eb1-37b2-f09d-8bfd-5615a56af53f
273. Technical name: Biochemical Analyzer
274. Diagnostické zdravotnické prostředky in vitro
275. Urgent Field Safety Notice for Chevalier Valvulotome by LeMaitre Vascular, Inc.
276. 285023a8-2dfd-11cf-bc14-ce2e2734be5b
277. 55e4c3d2-bb55-533d-113f-316799b4d76f
278. 0bf84d84-d55a-0ce5-0caa-0c500c2a9d0f
279. 7fe8b28a-2cba-1317-8ce0-3bbd33589d0d
280. Technical name: Biochemical Analyzer
281. 9b764489-6ae2-edbc-09cf-0c939dabbfda
282. 86f066df-15f8-ace6-bda3-1e5fb8e15ffc
283. Urgent Field Safety Notice for NIM Vital Console, NIM Vital Patient Interface 4 Channel…
284. 7dccdf89-2b5d-c5e9-2037-360165d507d2
285. Technical name: CREATINOKINASE ISOENZYME ACTIVITY
286. Diagnostické zdravotnické prostředky in vitro
287. Urgent Field Safety Notice for croBEE Real-Time PCR System by GeneProof, a.s.
288. 4acd7f73-70da-9052-1933-11d1e02642f6
289. f8d8cefa-34af-71fa-fae3-0986c65dbc75
290. Ανάκληση παρτίδων 20140528 και 20150120 του ιατροτεχνολογικού προϊόντος ICO (plus 3)…
291. Ανάκληση των παρτίδων O167A, P170A και O277C του ιατροτεχνολογικού προϊόντος Pe-Ha-Visco…
292. Technical name: TRIGLYCERIDE
293. Zdravotnické prostředky pro jednorázové použití
294. 05344e3b-4d9b-cdc2-77c6-1011621a1269
295. e4a7b36d-dc58-1867-e989-08685dd9e81d
296. 27ba285d-a99d-f4a1-e7b9-9b2b3f87c3e3
297. 08902f2b-32dd-1fe1-2326-a43e4a5c9f48
298. 0fd7096f-0bec-fdbc-0f21-a373a7bc40f4
299. LOGIQ P6 BT09 systems
300. 54b25fa5-2ebb-9eaa-7ce4-467aee5508b3
301. 08081d55-b750-6d86-e924-84821d4ccfe1
302. Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc.
303. ArcRoyal procedure packs
304. 21797ef9-bf03-3bd6-adb0-e7eededfd1f0
305. Centricity Universal Viewer
306. Nal von minden GmbH NADAL Strep A Test - tagasikutsumine, suurenenud valepositiivsete…
307. Venovo Venous Stent System
308. PrisMax V2 TO PrisMax V3 UPGRADE KIT
309. AXIUS XPOSE 3 Access Device
310. 3127cea4-9d22-a99e-766e-082b40c8027b
311. Mod. rev. neck lateral with screw 60
312. Optisure Dual Coil Defibrillation lead
313. Nimbus 4 & Nimbus Professional
314. OneTouch Verio Pro
315. 26e9a120-2480-f1d4-ba13-edbaec62dc58
316. Maxcem Elite
317. TC-PLUS Solution, Tibial Component, cemented
318. Resolution Clip
319. Vigilance II Monitor
320. Alumina Femoral Ceramic Head-V40 Taper +0.0mm
321. Triage Cardiac Panel
322. Multi Diagnost Eleva
323. EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
324. Volumed VP7000 Classic Plus
325. HemosIL ReadiPlasTin
326. DOYEN-COLLIN MOUTH GAG 120MM
327. RNeasy DSP FFPE Kit
328. OP Leuchte iLED 3
329. Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors 22.12.2010
330. Aqualine, Aqualine S, Aqualine RCA, Aqualine D
331. Artis Q, Artis Q Zen
332. Vapotherm Oxygen Assist Module (OAM)
333. CE INFUSOR LV 2, 12 Pack
334. RA-71726 20ml TransFix (2019-11-11)
335. INFUSION PUMPS / GENERAL
336. SUTURE UNITS, AUTOMATIC Staples, Fabrics
337. Zdravotnické prostředky pro diagnostiku a terapii zářením
338. Technical name: PROGESTERONE
339. Zdravotnické prostředky pro diagnostiku a terapii zářením
340. 70edf6dc-5ded-118a-e161-15ee2fd7314b
341. Urgent Field Safety Notice for N Antiserum to Human IgG by Siemens Healthcare Diagnostics…
342. 6e788867-6955-e195-d1e1-ec2b693044b9
343. Recently, there have been several reports regarding vein graft anastomosis failure due to…
344. 0e2562eb-68bd-ebfb-063e-aef376e3c508
345. This product is part of the Inspired Flow product line and is distributed independently…
346. 824eb428-e6ee-f71a-7d77-e6604b26fa09
347. 585d0f28-5227-c8c9-9ebc-af6038dd894a
348. 5fcf6d12-905b-9e6b-51d8-853992d2ddd5
349. When a medical institution conducted a "battery inspection" on this product, it was found…
350. b48ca4df-1c89-8453-2f03-4604670fd994
351. f0994458-50f0-276c-1996-244d408f953b
352. 2c225a42-f4e6-4834-aaf7-cc135b6b1d97
353. 4b10cd1e-5b79-db30-e557-174ed5ef8f21
354. 70b15869-16c1-4eb7-c14e-a64196db1738
355. Foreign manufacturers are manufacturing motor assemblies that may contain incompatible…
356. This product has two different pastes filled separately in the delivery syringe, and when…
357. Regarding this product, there was information about a defect with an average of one broken…
358. At an external sterilization facility contracted by an overseas manufacturer…
359. From the manufacturer Electro Medical Systems S.A., at the manufacturing facility (Steril…
360. 85412452-8f3b-0bdb-87bc-b041e1995305
361. The manufacturer of this product will sterilize it at the sterilization facility (Steril…
362. 51dad9f0-0d03-760a-1663-de09fbbbe7e3
363. The misalignment between the collimator's light field and the X-ray field may not meet the…
364. Domestic medical institutions have notified us that the specifications differ from those…
365. In some of the products in the lot, when the screw cap was tightened due to poor molding…
366. At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization…
367. f01b88cd-81b1-8bac-0f34-7ed0a1f5f8b2
368. An overseas manufacturer reports that the device will not start or will not start due to…
369. At sterilization facilities where overseas manufacturers outsource the sterilization…
370. The manufacturer has stated that water was supplied to the automatic water supply type…
371. c88eb917-2451-41a2-f8b2-75ef90651dd4
372. The multi-function pedal, which is a component of this product, allows you to press the…
373. Urgent Field Safety Notice for ACUSON Redwood by Siemens Medical Solutions USA, Inc…
374. 96f7b786-c67d-b4f5-da9e-4ff4a66371d2
375. dabb2c8e-7f3f-29fd-181d-fc1fedb787be
376. According to the manufacturer, when measuring creatinine with the medical device, in rare…
377. c40b8175-ac44-43d2-f1e7-25003b73e2a7
378. Some of the sterilization packs used for some products lack the strength of the heat seal…
379. Technical name: HOMOCYSTEINE
380. 402b2fda-70ae-d892-c325-cb86782d8349
381. We have identified a product that is incorrectly labeled as 13 instead of 1 on the legal…
382. SCS screwdriver product number 046.401 (lot EHG85) and product number 046.402 (lot EHG85)…
383. Regarding stainless steel and silicone, which are the raw materials for this product, raw…
384. For product numbers #55 and above, the tests specified in the certificate (torsion test…
385. For product numbers #55 and above, the tests specified in the certificate (torsion test…
386. The general name of this product is "Electric Dental File", but the product number…
387. Depending on the type of X-ray device and imaging table used in combination, lower bone…
388. This product is an endoscopic active instrument that performs procedures such as tissue…
389. This multifilament suture is used to harden the end surface of the suture during…
390. This multifilament suture is used to harden the end surface of the suture during…
391. This multifilament suture is used to harden the end surface of the suture during…
392. The product in question was not properly sterilized with ethylene oxide gas, and sterility…
393. e6c8f554-b575-fdaf-91e4-0624924f44cf
394. From the manufacturer Xmed S.R.L., the factory that performs the sterilization process…
395. The content of the manufacturing and sales notification for this product is considered to…
396. Some lots (Lot 3000000028) of "Quantra QPlus Cartridge" from the American manufacturer…
397. 757fc9b1-3b09-c65e-d0f6-7850e925828f
398. We are voluntarily recalling the affected products due to an error in the address of the…
399. In a specification verification test at an overseas manufacturer, the sterilized packaging…
400. As a result of an investigation by an overseas manufacturer, a special It was discovered…
401. This product has been tested for strength in the torsional direction at the time of…
402. cbf57582-e2e2-9bdf-e457-04f8ce8b5fea
403. Records that the sterilization process was carried out appropriately cannot be confirmed…
404. 5d199da6-01e2-72bc-9810-8b1179dac6d5
405. During the ethylene oxide gas sterilization of the product, a biological indicator (BI)…
406. In the "sterilized silk suture Manny Silk" that is included in the kit products…
407. During an external parts supplier's appearance inspection during the process of forming…
408. In some lots of the Trapper Exchange Device (hereinafter referred to as the "Product")…
409. We have received a report from a medical institution to which we supply the product that a…
410. Ethylene oxide sterilization has been verified at the manufacturing facility (Steril…
411. Delivery catheter system that is a component of the Core Valve Evolut R, Core Valve Evolut…
412. It has been discovered that some of the balloon compliance charts included in the package…
413. 219a1473-f67f-73b4-eae1-68afb3bc27c1
414. In the manufacturing lot of the product in question, an intermediate inspection found that…
415. 7ebc45af-d03c-f5e6-82d8-a88e28a510de
416. We have been informed by an overseas manufacturer that the plunger of this product may…
417. We have received multiple complaints that some lots of this product cannot be sutured…
418. Target product (sales name: Endoscopic Powered Linear Cutter, product number: PSEE60A)…
419. Recently, the Japan Medical Devices Agency (Independent Administrative Agency) has issued…
420. In Japan and overseas, the catalog number of the product's legal display label (overseas…
421. We received a report from a medical institution to which we supply blood leaking from the…
422. 557cd47f-8c59-fa40-a17b-6725afa892a9
423. 3c09f385-aab1-96c2-3989-f979c0d58761
424. A medical facility has reported that the amount of blood collected for some products of…
425. 43ff8d5c-7256-14db-3ad4-c8d358cfad79
426. Regarding the Terfusion infusion set, which is a component of the kit, the sterilization…
427. This item (selling name: Spline O-ring, certification number: 222AGBZX00047000) has been…
428. bd9a8f01-99e7-ae55-0cb8-6e066929af8e
429. Due to a notification from a foreign manufacturer, some of these products may have…
430. We received a report of a problem that the main battery of this device was emitting smoke…
431. 7d936faa-f2e1-d173-b581-63952b7427e9
432. bcd4f0ce-e189-c6bb-f53d-75e80706cfa6
433. When we investigated in-house inventory based on defect information provided by customers…
434. The product may have been sterilized at a different sterilization facility than stated in…
435. 0292c21f-1994-0316-c548-984c9cd840e2
436. 6fe976c8-fc7e-36c0-eba4-730146c4c4cd
437. 1ec219ea-2b9c-d41a-8d21-79dea63e27dc
438. d5117b2a-3030-3629-4fa9-1c27d820694e
439. Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter…
440. 693b6866-426e-f273-7c95-5137f8e6791e
441. 6ae43505-a274-f19b-45c4-fbe6185c8b73
442. 3c0646a4-4531-6e32-ef6d-e6c4d3a3943b
443. Technical name: Centurion Vision System
444. Diagnostické zdravotnické prostředky in vitro
445. 2481f294-4676-5e03-cec4-9442249bd041
446. Adhesion of guide wire lumens and Y-hubs observed during preparation or use in some lots…
447. On some parts of this device, pressing the front operation panel buttons (power ON/OFF…
448. 1521d2d4-105f-f7ea-5852-1dc4efc5c1aa
449. eef43e85-5681-151e-7389-e997206c2166
450. e759dabb-c0e4-5e95-6a7d-5e7f1ddb0714
451. Due to a report from the manufacturer, there is a discrepancy between the information…
452. A situation in which the anchor thread incorporated in this product gets caught in the gap…
453. Our company and the overseas manufacturer have received reports of cases in which the…
454. e5aa692b-d237-f23f-8dc8-1d60a681eb05
455. 63fb04ee-96d4-384b-c824-d9303690b236
456. Our product “Catheter/Connector for Tube Exchange/Intubation” (product number…
457. 61116157-62ef-36a2-2540-09923c06c678
458. Regarding our kit product, we have received a report from a customer that the type of…
459. 59a66973-5e93-1f74-f13f-41dad6032ded
460. c06f027a-261c-8c5d-ec5a-67cfa86a8425
461. We received a call from a medical institution that the pump door was wobbling when opening…
462. 27 of the products were voluntarily recalled between March 17, 2020 and May 25, 2020 due…
463. Previously, this product was manufactured and sold as a separate reusable item called…
464. We decided to recall the product after receiving information from a medical institution…
465. This product (hereinafter referred to as the trial) is used to check joint movement during…
466. A foreign manufacturer stated, ``We have confirmed one case in a foreign country where the…
467. An overseas manufacturer has announced that some products in affected lots may not…
468. de0702cf-246e-ab35-7acc-3e2e2caef375
469. We have discovered that unintended fibers may appear on the surface of some of these…
470. We have received three reports of product leaks in Japan and overseas. After receiving the…
471. As of June 18, 2021, we conducted a voluntary recall for the same reason, and as a result…
472. Due to a software glitch, the oronasal respiration waveform data recorded on the 1st day…
473. 77d9ecff-4c79-75de-2e89-7c0cf3effcec
474. d2d71675-f8c8-21d2-89f2-a6cf986097a1
475. c27ffaeb-fd66-7065-f713-f76b71289525
476. An overseas manufacturer has issued the following three problems due to a software bug…
477. 93ae42e0-4137-84ca-7751-409155a8c234
478. Regarding the Portex stylet that we manufacture and sell, we received a request from a…
479. We have received notification from an overseas manufacturer that the pilot balloon may not…
480. Although the header and housing of this product are ultrasonically welded, there have been…
481. Urgent Field Safety Notice for IMMULITE 2000, IMMULITE 2000XPi by Siemens Healthcare…
482. During the domestic acceptance inspection of the products in question, a leak was…
483. From July 2020 to August 2021, the built-in malleable wire will be removed from the tip of…
484. In the relevant lot, a blade with a different shape from the original was manufactured due…
485. Regarding the products subject to recall, a product that did not meet the required…
486. This product is an instrument used for hemodynamic measurements, angiography and other…
487. As a result of an investigation at an overseas manufacturer, the number of reports of…
488. Regarding this product, we have received a report from a medical institution that liquid…
489. 71aa5312-8697-0fd6-838a-346a32565ae0
490. Twin Tube and Twin Tube Probenschlauch
491. d335bff9-359c-6e9f-f460-7190ec4ca665
492. The adhesive part of the tip nozzle of the cone tip (hereinafter referred to as this…
493. The product in question displays the remaining battery power using an indicator, but even…
494. The wire was originally not torqued, but we received a report from a customer that torque…
495. Technical name: Bone Distractor
496. Diagnostické zdravotnické prostředky in vitro
497. f6fdef44-d559-777b-9ce2-c9c5c633b908
498. The methacrylate used in the "Serbix applicator" (hereinafter referred to as "this…
499. 34c0b8af-20fe-f465-8c95-2840e0214bc1
500. 4cdeafaa-1b9d-e8e8-5b17-a31439f9113b
501. Due to a bug in the medical device program, the distance measurement function and area…
502. As a result of an investigation at an overseas manufacturer, we found that Bio-Medicus N…
503. We have received reports that the adhesive on the tip of this product peeled off during…
504. d90aa36f-d44e-72aa-d895-2e094bc3fd91
505. ef9739e3-54f3-b3e7-32a3-7e53ed2c3ae6
506. 5f100e73-cd2e-3c32-0b57-1f84be462433
507. In the process of treating and improving malocclusion, this product uses the elastic force…
508. 962edac6-9063-2596-2aff-50a4210be9ab
509. Carbon plastic snaps (hereinafter referred to as studs) and grommets (hereinafter referred…
510. Urgent Field Safety Notice for Power Knee by Össur hf.
511. The tool is a drill sleeve that is fixed to the radial bone plate to determine the…
512. After obtaining medical device manufacturing and sales approval in 2008, due to a lack of…
513. Conventionally, the plunger gasket (black rubber on the piston) was made of latex-free…
514. 687cb143-178c-48ca-9dd2-6fd279eb8e21
515. eccf2cda-e2f1-d66a-0e79-e200411dd58a
516. 7d494eef-945b-800b-9a4c-49c60fd20a08
517. 3caa4871-06e7-ea90-5dec-3086db85bdb9
518. 2f85c3ca-a90c-7516-c19b-d74cfd639dbd
519. 01522ed0-f70b-9af0-1dda-7964ddda5091
520. This product has different color tones between white and clear (nearly transparent white)…
521. 0088677c-99ba-ece3-f246-3a15a6dbf666
522. b0368537-fcca-6f7b-65e5-944fedbaa278
523. Between July and September 2021, we received multiple reports that the puncture needle…
524. e88dd378-1b88-d909-4ebe-5698775dc809
525. ff64a70b-702e-30fc-bd0c-7df836d322ab
526. The manufacturer conducted a periodic mold qualification re-evaluation of the plastic hub…
527. e80b1d65-50cc-f2df-e306-8b234cdfc576
528. It has been discovered that some lots of BD Faseal IV line connection kits have incorrect…
529. 3e224e27-fd35-cf61-fdab-7746d99ddd47
530. d8a88e8a-c3c5-aba0-8455-8ce3bced610f
531. This product has a component called a "retainer" that fixes the reservoir used in…
532. The product was voluntarily recalled on December 11, 2019 due to a defect in the…
533. Due to the possibility that a product with a different tip shape was mixed in during a…
534. The outer diameter of the tip of this product is 25G (0.5mm), but some products with an…
535. It was discovered that a product whose main body could not be peeled off from the release…
536. 2d47d8b9-2f23-a3da-cfa3-66656f4fcc49
537. 7675c819-6c4f-7ab4-8cb1-95a10fbf631d
538. f7e5d9ad-bebb-5b5a-dd29-95772936df98
539. For two production lots of dental implants from an overseas manufacturer, the internal…
540. The U.S. manufacturer received a request from its supplier regarding the plastic washer…
541. As a result of an investigation by the overseas manufacturer, some parts of the delivery…
542. c5828eb9-04d5-8ec3-c934-69c664034ffd
543. 41170fbb-ad60-6039-1073-a5d88bbe7656
544. In some lots of RX Hurricane Dilatation Balloons (hereinafter referred to as "this…
545. Regarding this product, when connected to a Nipro pressure pump (hereinafter referred to…
546. At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization…
547. 334c4e1e-b890-8bd8-df50-6b9e945e43b6
548. 94039f08-fa90-c9df-168d-b75245867792
549. Validation of the cushioning material used in the packaging of "Integra Graft for Dermal…
550. Urgent Field Safety Notice for various Wire Guides, Vinyl Connecting Tubes by Cook…
551. 080bcaaf-94c9-68ef-a559-6020a7dc4194
552. b96845cc-939a-1420-96bb-754c2df428ee
553. a86f1c24-68c2-e01a-3619-bc9ef192ca10
554. 4cedecca-8be2-ec45-7d06-37dd2e600948
555. f20ed739-cee4-c6b2-cb1c-628442d283b0
556. We have recently received a report that the hose part of the APEX Wizard 510 mask has…
557. Regarding the product, the general name should be changed to controlled medical device…
558. Urgent Field Safety Notice for Tourni-Cot Universal by Mar-Med
559. 186733d3-2ccd-0eb8-b1af-bd1d201b5098
560. Operating time after loading new dry batteries as stated in the instruction manual…
561. As a result of an internal investigation, we found that the component supplier's…
562. a73495dc-43e1-320d-5656-f6f4de3dfb59
563. After a sampling inspection, we discovered a slight crack in the casing of this product…
564. Technical name: Vital Signs Monitor
565. Aktivní implantabilní zdravotnické prostředky
566. 21 products eligible for "Arthrex Ankle Fracture Plate Ti" (see 2. Target lots…
567. This product is an absorbable suture. Since we received notification that there is a…
568. In some Affinity Pixie oxygenator products, the raw materials used in the Luer connector…
569. At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization…
570. At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization…
571. a7e6d4e2-60a7-b61c-c67a-05421e6070e4
572. A medical institution we supply to has informed us that during an inspection of the pump…
573. As a result of an investigation at an overseas manufacturer, it was found that the welded…
574. This product consists of a cannula and an obturator, and when used in combination, A…
575. 19f68fcb-dcf6-ea15-a8ae-e6b10981c9a8
576. Urgent Field Safety Notice for 3M Lingual Retainer Wire by 3M Company
577. We have received complaints both in Japan and overseas that the catalog number on the…
578. At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization…
579. 121d1eec-1976-a6fb-e66e-ac5837667ce8
580. c27e23bb-083a-fee9-19f1-d9583a4a0c8d
581. 7d70b12a-65e7-00e0-6b67-4fa8990b0faf
582. f8c54814-f944-31c4-4449-c4f2f3c515da
583. a90a89f6-faf4-6068-813f-057798bb9348
584. ebd77189-b57b-ad4f-716c-899de72132e1
585. Due to the possibility of damage to the sterile packaging of products using blister packs…
586. There are variations in the inner diameter dimensions in some processed parts of this…
587. 6f98c489-e8ef-2e3b-e4ce-8bc7e5b2c44a
588. dfaeaa85-3ee8-e8d5-9566-4aba087cca49
589. Based on information from the market, it has been discovered that the yoke pin is bent…
590. Based on information from the market, it has been discovered that the yoke pin is bent…
591. Based on information from the market, it has been discovered that the yoke pin is bent…
592. 368f7cff-88c7-2f38-1c56-a8fc36c95a0a
593. Red phosphorus added to the insulating resin of AC adapter plugs generates phosphoric acid…
594. It has been discovered that some lots of this product may have a defective seal on the…
595. Some lots of "Ospica VACSII" from Ospica AG in Germany (Lot P338820-06)(*) It was…
596. 9cb4cda1-0ea7-9ea4-79be-6f7ee8a1e676
597. We received a report from an overseas medical institution that there was a shortage of…
598. 7039cbb3-2463-891f-5cb2-f6fb2e92cb08
599. There was a report that an identification label indicating product number 0112-20J was…
600. 63187aa7-0fe8-a8ca-253c-d05005524d95
601. fc6b99f5-322c-0a1f-2aba-65f2cfd3353b
602. Regarding some lots of "Jagtome RX" (hereinafter referred to as "this product"), the…
603. aef5cb4f-5500-ad41-0673-a350fbde8c0d
604. This product is an artificial shoulder joint system (humerus side) that is used to…
605. Our manufacturer's investigation revealed that some of the products in the target lot had…
606. 1c3559dd-36c2-e552-9cf9-b38151c6be2c
607. This product is made of non-natural rubber (latex free) used in surgery to protect…
608. We are conducting a voluntary recall of this product due to a continuing problem in which…
609. Regarding this product, the manufacturer, B.Brown S.A. Spain, has confirmed that sterile…
610. 6fe51143-d7b4-973c-6a87-1ab07be2c5e7
611. c2e291bb-7f23-910c-775c-ae1d7f3cccff
612. ac325073-7c99-ecff-53d9-6fef0afca2a7
613. A domestic medical institution said that the effective length displayed on the label was…
614. e1c1c5c9-84f2-246c-e7f8-c1b3dc7e4485
615. 8874d1e6-7998-bfde-9c38-bee665560210
616. 28b24bc1-e045-1f2c-a195-b869333f8e9c
617. Although the product should have been approved as a controlled medical device, it was…
618. When carrying out collection work within our company's collection process, a legal display…
619. I forgot to paste the display label on the exterior, and the brand name displayed on the…
620. We have received one complaint regarding the product containing brown foreign matter…
621. 1fb66b3e-8d9f-fe24-7050-8b4736e201df
622. The certified "purpose of use or effect" states that "application within root canals is…
623. 73724d49-c678-792d-b058-e0068fd56f86
624. As a result of an investigation at an overseas manufacturer, an electrode check was…
625. d6fc9067-0ff8-60ad-ef3f-2ec80fe9143a
626. We received a report from the market that a crimp failure was observed in the sealing part…
627. The "Atom Infusion Pump AS-800" manufactured and sold by our company will be JIS T 060…
628. Technical name: Glucose / Lactate / TRIGLYCERIDES / URIC ACID
629. Zdravotnické prostředky pro jednorázové použití
630. 91760055-b351-b23c-f770-7b023cef586f
631. c96734a7-a4f8-6960-1a3a-620d0c1142c2
632. This product is a normal type screw, but some batches from overseas manufacturers have…
633. Medical institutions in Japan have reported that the LCD screen does not display and…
634. Regarding the kit product, an internal investigation revealed that there was a procedural…
635. 728f5965-7e14-5c29-1750-4c87a43d4d3a
636. A medical institution has reported that the product is stuck and cannot be unrolled…
637. For the product, the expiry date on the legal label should have been "December 31, 2021,"…
638. The product was recalled because it was confirmed that the piping inside the product came…
639. Urgent Field Safety Notice for Fungitell S.A. by Associates of Cape Co., Inc.
640. This product is an insole made of vegetable carbon fiber whose main purpose is to promote…
641. 9330e5c4-e7d0-724e-331f-7470bdf63822
642. fdfacdc8-f03b-2750-d9a2-963158b25ca6
643. It was discovered that the legal label and package insert for a different product had been…
644. b7f6aa0a-bc79-ea60-7c95-6043fad21cb0
645. During our in-house process, we confirmed that there were holes in the cover membrane…
646. e34f1cfb-c50e-193d-5fd2-bcb952555c5a
647. 7a7f8c3d-1a41-47f2-7722-f4af544f4752
648. It was discovered that the product in question had been shipped with a stent that had a…
649. 3c231157-fabf-7796-14df-1e24d9b46724
650. Because we did not fully understand the Pharmaceutical and Medical Devices Act, we were…
651. This product is a stem head used on the femoral side to replace the hip joint function…
652. 6fbf5881-5c4c-3ff0-48e3-dd8bc4cd8ded
653. cadcb22c-0e33-9189-4cbc-d6a7378a1285
654. 3155ac38-5b70-33c0-b839-3ffb82316189
655. In the specific lot numbers of "PCCO Monitoring Kit II" and "ProAQT Sensor" manufactured…
656. 4c4349a5-8f6b-f604-7f5d-af3806a0bb9c
657. 63128a88-f326-9b23-5f72-4a20cc1af51f
658. We have received information that the lot number displayed on the label is different…
659. "VA Locking Screw Ti 3.0 x 26 mm (Sterilized)" (AR-8933V-26S) In a specific lot, the size…
660. b1f3c84f-3834-34b8-f672-a88ba1018e52
661. There is a problem with the yoke, which is a part of the product, and the yoke pin is…
662. The diameter of the tip of the NEXTRA Sterile Instrument: Driver for the proximal phalanx…
663. We have received information from a customer that the sterile packaging of the product in…
664. e5e69e21-4e00-b78f-5387-9abad8b15fd2
665. 742c870b-4c9a-0187-603e-e36bd47c100c
666. 71a7c13b-24f7-5115-1917-a95b2f9bbc30
667. 1b16f6eb-6135-1b6d-1d87-7424149ec842
668. 501df951-4990-f260-0444-f8aefe6da7c6
669. There was no seal on one of the four sides of the inner bag of the Ingrown Tsume Meister.
670. It was discovered that some products in the manufacturer's inventory had 0.2-0.5mm pieces…
671. 8eeb737e-e47d-372f-2f6b-bd23bef1e6e9
672. The overseas manufacturer has confirmed that the pediatric SMART pad cartridge (HeartStart…
673. An overseas manufacturing facility sent a message saying, ``The hemostasis valve (Y…
674. A problem has occurred in Japan where the adhesive part of the circuit comes off and falls…
675. At an overseas manufacturer, some lots of "Rotor Wire Drive" have weak seals in sterilized…
676. A medical institution pointed out that the shape was different from the product…
677. The following events have been confirmed in specific lots from markets around the world…
678. f2ea7e4c-47fc-112b-7e5e-9316167213c6
679. Technical name: Biochemical Analyzer/ Biochemical Analyzer
680. Elektromechanické zdravotnické prostředky
681. 30157092-22b5-75e2-207f-03b41118806e
682. Period when the registration of medical device manufacturing industry in Kanagawa…
683. 81a80556-3eaa-72bf-9fb5-6181ffde5821
684. Changes have been made to certain manufacturing lines for some IN.PACT Admiral drug-coated…
685. Medical institutions in Japan and overseas have reported that “Contact Force Catheter is…
686. This product was originally classified as Class II, with the general name of the target…
687. 6f3167db-b26b-e486-1e5f-972f7bf62081
688. fc2dc5aa-a9e2-f70f-ef16-b56d2ac1c738
689. d264f151-8ad6-c83a-417c-dd01b8983382
690. 39c32224-4d00-490f-66fa-5f995a9350aa
691. d07b64b3-42c5-8220-8254-4d9b06d67fe3
692. If you use it immediately after installing the battery, it will work normally, but if you…
693. 6c29d230-9e44-518a-ec2d-59cf8a5c7f77
694. One lot (H1JAC311) of "Hemoclone Test Cartridge (Model: JACT+)" manufactured by Acriva was…
695. 987fd552-b52e-f3d0-6293-610378f850cc
696. For some serial numbers of this product, parts used to repair the insertion tube may be…
697. 3b32bf30-864b-5ad8-d130-010f0bc89259
698. 5cfcc674-f3ce-7d68-abe5-a6154a51101d
699. In certain lots of this product, the proximal marker attached to the shaft has moved from…
700. In some cases of the ConMed suction/irrigation series (hereinafter referred to as this…
701. During an in-house bench test at a foreign manufacturer, one of the two processors that…
702. When using the circuit from the vendor at a medical institution, a different connector is…
703. ba93e721-79f4-0f6b-bf88-83de42bc1115
704. fa4b03e6-6726-4d6e-c443-6490adaae13f
705. 14189e4c-a5d7-8392-e561-d037c8e4c814
706. Some lots (Lot P3) of "Ospica external pacemaker relay cable (model number: D2P-SP)" were…
707. Regarding "Aion Acti-PRP" manufactured and sold by EPJ Medical Service Co., Ltd., the…
708. 999481c1-77e5-adf9-79bb-92f0ee8fb76f
709. The results of a sterilization verification test conducted by an overseas manufacturer…
710. e14bbff7-f9cc-6a3b-fa82-521dc4a3ddff
711. Urgent Field Safety Notice for PST 500 by Baxter Medical Systems GmbH + Co. KG
712. As a result of an investigation based on information from medical institutions, we found…
713. During the pre-shipment inspection of this product, it was confirmed that foreign matter…
714. 2fc7b862-c8c0-c05f-0630-baaf3ebace64
715. The affected product (sales name: Endopath Surgery Probe, product number: EPS06) has been…
716. A clogged Dräger sterilization filter (Safestar) from an overseas manufacturer was used on…
717. The catheter and ultrasound images displayed on the screen when this product is connected…
718. 2d6d3550-bb62-be7b-85f1-019c8ebf03b2
719. Applicable product (sales name: BVI cannula (flow-through), product number: FT-12150, lot…
720. bd7aac43-183f-4b11-4c42-c6162c18591b
721. For some EEA circular stapler products with a cartridge outer diameter of 25 mm, the…
722. 61380037-eaaa-7910-66a8-e3dfa8de3e2e
723. Regarding the relevant kit products, Japan has reported that the marker position of the…
724. 1bc51684-00b5-ba3b-5bf1-b2444d47ff92
725. 0ad3a541-371e-2df5-e534-c23b036bd8bd
726. This product has been certified as a Class II controlled medical device under the general…
727. The product in question does not meet our standards for the amount of force required to…
728. It has been discovered that the overseas manufacturing facility for this product has been…
729. Regarding this product, a medical institution has reported that liquid leaks from the…
730. Urgent Field Safety Notice for VIDAS 3 System by BioMérieux SA
731. It was discovered that a product was being shipped that had a defect in the pre-shipment…
732. 24c0753d-1be1-53e9-58be-f269c0d71723
733. 7efe6207-3692-bca3-621d-22acd9dff1b8
734. Regarding the affected products, when a syringe or extension tube was connected to the…
735. Some products manufactured by overseas manufacturers during a certain period may not be…
736. 773bd56c-80b8-7a78-a5bb-c329a421c42d
737. c8de4263-153e-afdc-fbcb-97ee3a012c58
738. e8c88a4a-e7b5-db6c-c9cd-f38e0c1c407e
739. A medical institution in Japan has informed us that in a specific lot, the tube between…
740. 03a7643b-0d2f-8e95-080d-c0aeeb9b706b
741. Technical name: PHENYTOIN
742. Diagnostické zdravotnické prostředky in vitro
743. 7d2ed48d-6b23-da48-6e88-414529f90c24
744. This product is a specialized infrared-enabled video camera designed for use with…
745. 84ce72bf-d6a5-417a-0ac4-12dc81340f35
746. 879a74ca-f9a4-f907-eb1a-99abfb4a309e
747. Urgent Field Safety Notice for Portex Loss Of Resistance Device by Smiths Medical ASD…
748. The retaining ring may be missing and the liner cannot be secured to the cup, so we will…
749. e6c5fe6d-f0ae-7d9d-0c6b-9ce02dfd62a7
750. When we inspected this product at a medical facility, we received a report that it was…
751. 1854f1c3-fece-0d95-f661-dd80735d7642
752. The magnetic flux density, which is a standard related to product performance and safety…
753. During manufacturing, it was discovered that some products may have leaks within the…
754. 0581c6b3-f637-c334-17f4-78a2a65eba42
755. 50795442-dc96-fb96-eb83-f1c2ace48646
756. e2092ccc-4258-186b-eeca-aca47153af24
757. e2ef1d2f-faec-90ef-c070-69825683a886
758. Zeltiq Aesthetics, Inc continues to collect information on adverse events of paradoxical…
759. We have received reports of leaks occurring from the lock adapter part of the product in a…
760. 4a5ac1f9-dc54-a27c-3643-6955fe76ce54
761. On July 5, 2021, we received a report of a problem that the oxygen concentration of this…
762. Cobalt MRI ICD series and Cobalt MRI CRT-D series from overseas manufacturers Insufficient…
763. We have received information that the information on the label on the product box and the…
764. 49a18122-839e-de30-3d70-0781828f10fd
765. Some tests conducted during inspections at overseas factories (targeting E-100s that have…
766. 3a239ef0-8678-49cb-685e-727aa282e2d9
767. Component medical device "Connector three-way stopcock" incorporated in the kit product…
768. The manufacturer of the connector has received a report that leakage occurs from the lock…
769. f0c46a7a-a6b6-5602-4583-580f34bf00f7
770. Medical institutions in Japan have reported cases of leaks occurring from the hubs of…
771. After contacting the overseas manufacturer, it was discovered that there may be rust on…
772. A medical institution in Japan told me that the female connector and male connector of…
773. 7c535d47-4a3b-dcf4-e0fa-2c9923acba75
774. debda8ae-7f43-70f0-7549-d0f88d8709b3
775. 3c32e046-fd7c-e420-1075-ba7c30c2203a
776. a18fd2f6-231b-d576-7b66-4a69f645df8c
777. 40a50d0c-d989-979a-88e2-b3b711775ff9
778. After receiving a report of a problem with the angle function from a domestic medical…
779. At an overseas manufacturer, a leak occurred in some lots of three-way stopcocks from the…
780. Medical institutions in Japan have reported cases of leaks occurring from catheter hubs…
781. a29dddcd-6fc8-3a3c-b885-6ca98c6fa590
782. 42608f05-65ab-8e44-e1fd-ed106551988a
783. ba72a0ab-1b36-4e6a-ed9c-0c8a5d094de0
784. 0d1eeef7-7939-7a07-59ec-5259dbce2147
785. 66ccc27c-5a02-82e1-a2bd-c75969913379
786. Recently, a foreign manufacturer has confirmed that one lot of sterile packaging materials…
787. 3fd7a917-d50a-5f04-a9d3-512690de8a12
788. 5f5fd05f-d513-163d-d779-6788b35e29f0
789. This time, between two types of display standards for product packages…
790. Medical institutions in Japan have reported multiple cases in which water leakage was…
791. We were informed by the market that there was an error in the labeling of the secondary…
792. 3bcd0f52-341d-1170-d37e-2a2929a5f0b9
793. After investigating a complaint, a foreign manufacturer found that the COOK Zenith…
794. An internal investigation revealed that the actual status of the manufacturing facility…
795. 59a59cbe-cb07-8026-f2a6-700de6a12f4b
796. bb06209c-5ec2-4650-6812-cac134187210
797. 608c7996-8a9a-c7e0-bd4c-c74521290d31
798. 5bafd038-6413-59f8-7063-594dd9c7b8cb
799. The lot was manufactured and shipped at a manufacturing facility (storage of final…
800. 022af5a3-c742-b743-3c65-0f6747ca4875
801. eb5704a1-0dd4-9126-c487-2b6d4dcfeed3
802. Target product (sale name: PDS suture thread, product number: Z771D, thread thickness…
803. 10d75504-f341-d923-a5ca-610ad0cf0f06
804. We have been informed by the market that there is a discrepancy between the catalog and…
805. Recently, a foreign manufacturer has reported that the seal on the chevron seal of sterile…
806. eba6b3f1-dce4-3d88-0175-b26534b7ea10
807. Products whose raw materials have been changed during the process of obtaining partial…
808. ICU Medical, a foreign special certification holder, has provided two halves that make up…
809. Technical name: SURGICAL INSTRUMENTS
810. Diagnostické zdravotnické prostředky in vitro
811. After investigating customer complaints received by overseas manufacturers from markets…
812. An overseas manufacturer has stated that when the user presses the trigger of this product…
813. 09f1cf06-f68a-2130-a831-a478ad393024
814. 2012a18d-c178-3981-16cf-ea374236ca5e
815. 54fd9238-7e22-d81c-e394-59ff839ba740
816. It was discovered that the product had been sterilized at a different sterilization…
817. Urgent Field Safety Notice for Hamilton H900 "Atemgasbefeuchter" by Hamilton Medical AG
818. The ZedKnee and JIGEN modules within ZedView simulate the placement of femoral components…
819. 419f3c68-9c28-601e-3659-542ee7d3f312
820. 16ec4a76-88aa-a4a9-a1a6-617bbb9f5b59
821. fe0a9305-e95b-b402-9ba1-497fad1e6bfa
822. 3eba56af-65c7-f9f9-9e2b-510f3f132cc1
823. Due to contact from the head office manufacturer, the English language affixed to the…
824. The results of a close examination of cases where the needle catheter, which is a…
825. Foreign manufacturers are manufacturing motor assemblies that may contain incompatible…
826. Domestic medical institutions have reported cases of contamination with products of…
827. For our nail system, we put cushioning material and attached documents in the individual…
828. There is a possibility that products are being shipped that may not meet the specified…
829. The odor of the parts (perfusion lure) used in the VERITAS Disposable Set II (VRT-AI) has…
830. We received information from a medical institution that ``threads break easily,'' so we…
831. 2ee954bd-50d9-4b2f-3128-0b0bcb8f39c1
832. A customer (outside of Japan) has reported that SpCO measurements were higher than…
833. f5a89cfc-a759-c192-e75d-24b730d648df
834. In some production lots of this product, products failed the quality inspection conducted…
835. The lithium-ion battery for the autopulse artificial resuscitation system has been fully…
836. A product was shipped to the market without being approved for release to the market. Some…
837. ed4ff734-657e-c1e5-2ebf-e9967afad6e7
838. 622346d7-7f9c-1c47-10c1-66fd9698977c
839. During our in-house operation checks of equipment manufactured by foreign manufacturers…
840. We have received information from an overseas manufacturer that the pin located inside the…
841. e058eb1c-c76a-05b5-249a-1bc4551c41b7
842. In some lots of ILS 0914-12 and ILS-0914-20 for use with ATEC handpieces in MRI-guided…
843. 25f30f40-7b76-78c1-10da-f429fde09a0c
844. 5b32fc3d-fe3a-0970-0a1e-ce62f09295da
845. We have received reports that the Maximum Expansion Pressure (RBP) on the compliance chart…
846. We received information from a medical institution that ``a product was contained in an…
847. We received a report from a medical facility that anti-cancer drugs may have been…
848. c20cd090-8855-8a53-b138-692197705992
849. c7757a46-7a47-d57d-e29a-e9dfb6d4b97f
850. The product in question is a household electric massager that is charged before use and…
851. a3c9f1e8-f703-33f3-40db-235ab1d7def6
852. 57d55000-fb91-0055-1efc-48cd1aaf8db4
853. Problems with balloons bursting, being damaged, not being able to inflate, leaking, and…
854. 3bee8525-d07a-9d58-0b7f-f031c4e568b6
855. It was discovered that the product in question may have been manufactured with a shaft…
856. b45a9639-2062-7552-7248-26f33a554d16
857. An overseas manufacturer has informed us that the product peels off easily when removed…
858. 215910e7-4ba0-1416-7f46-f2f6f3bdcab4
859. The Woven EndoBridge device is used to place prosthetic materials (implants) for promoting…
860. b6331367-faea-6efc-43fe-81283ba8ca79
861. NxTAG Respiratory Pathogen Panel & NxTAG Respiratory Pathogen Panel + SARS-CoV-2
862. Technical name: SURGICAL INSTRUMENTS
863. 7c0dfb2a-1024-adab-85a2-6d1d594a2686
864. d4deaabf-5c0c-68e4-4741-439beef9c027
865. Some of the target products are shipped without legally required labels affixed to the…
866. During the in-house repackaging process, a trace amount of foreign matter was found…
867. Even though the main assembly facility (overseas manufacturer) has changed, we have not…
868. f3b4cb83-2389-9b32-ab01-4ccf4751a1a1
869. 8be3c89a-526a-0fb3-df3a-4665afe4a601
870. It was discovered that the foreign manufacturer of the medical device related to the…
871. Even though the main assembly facility (overseas manufacturer) has changed, we have not…
872. Even though the main assembly facility (overseas manufacturer) has changed, we have not…
873. It was discovered that the tip of the product in question may have been shipped in an…
874. It is possible that a product was discovered overseas where the size of the packaged…
875. A report from a medical institution that an error message appears on the monitor screen of…
876. Complaint monitoring carried out by the overseas manufacturer Cordis revealed that the…
877. f4696dd5-adcd-a829-8512-14c6272dd7fc
878. MiniMed 670G Insulin Pump
879. It was found that the surface of the light guide in the target product was not coated. Due…
880. 8ffd59ab-6daf-a11c-93d1-8145e224089b
881. "3D fundus image imaging device 3D OCT-1 and 3D OCT-1 Type: Maestro2 ("Type ：Maestro2" is…
882. It has been reported that the two product lots contained a lens container with a different…
883. We have received notification from an overseas manufacturer that blood/medicine may leak…
884. efa79831-fbf9-27fe-f430-1e72edf7ac91
885. 83ceab41-4557-d83b-5292-b57b15e6c975
886. Software version 1.1.0. 1: The measurement tool has a maximum error of 14%. 2: If there is…
887. We have not applied for a QMS compliance investigation for the item manufactured and sold…
888. Medical institutions have reported multiple cases of leaks occurring from the connection…
889. 3efb46bc-4acc-479c-2a5b-d796a91e102a
890. c05a7051-bb8e-59bd-e8fc-5d8b7618a71d
891. Domestic and overseas customers have requested that thread trimming be performed when…
892. When charging the product, the LED blinks red, which is an error message indicating that…
893. At an overseas manufacturer, we have confirmed that a joint in the main body housing has…
894. 269e521d-2d1d-4a1f-5ceb-f1da19149715
895. 86180176-a599-84cd-0f6c-0783902766c9
896. In the total artificial hip joint (trade name: Ocean artificial hip joint) manufactured…
897. The probe tool, which is one of the components of the X-Guide component, originally had…
898. 6024e8a8-1fa4-18d0-c050-8d263425ec91
899. fdf0b7c0-12ab-2035-df72-93738a120c2a
900. 51d51c89-78da-2e8a-6f53-22c019466d51
901. 3c6800ef-cd21-7926-4f5e-a7b3a08aa547
902. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
903. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
904. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
905. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
906. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
907. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
908. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
909. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
910. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
911. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
912. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
913. Products subject to recall are those whose main assembly facility (overseas manufacturer)…
914. Ανάκληση αποστειρωμένων προϊόντων γάζας Για να δείτε την απόφαση, πατήστε εδώ
915. Due to the fact that some products were shipped with different specifications from those…
916. 1465caf8-d3dd-78eb-7463-6a3af0b22023
917. There is a possibility that gaps or wrinkles may have formed in the seal area during…
918. It was discovered that there was an error in the ingredients and amounts listed on the…
919. 126df21b-260e-fb7b-f77a-83e72e0e9b85
920. 4e88e499-b3d5-7cfd-e673-85d6f058dce8
921. d45526fb-d7c6-0ce3-9445-b46d7310244f
922. 3ae82dd4-98e4-470d-9c32-ad6247d93dbb
923. c06060ae-c6de-5cfb-dd7a-26edd9d9c131
924. b1284cb1-0745-4e10-dd7b-9d0936084561
925. 99afa6ce-f528-444b-66e2-fcfaaf09d23f
926. We have received a report from a domestic medical institution that some products have…