International device safety notices

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

1. Corrective action for the CentraLink™ Data Management System, Siemens Healthcare…
2. Urgent Field Safety Notice for RAPIDLab 348 Gas cartridge pack by Siemens Healthcare…
3. Recall for LIFECODES PAK 12G, Gen-Probe
4. Lot recall of Roadrunner UniGlide hydrophilic wire guide, Cook Medical Europe
5. Recall for the Bard® EnCor® Biopsy probes, Bard Limited
6. RPM Respiratory Gating
7. Urgent field safety notice for BeneVision N22 and N19 patient monitors, Shenzhen Mindray…
8. Lot recall of Acetabular Low Profile Screw, BIOMET
9. Recall for Endoscopy suture anchors, SMITH & NEPHEW
10. Recall of batches of Angled Surecan needles, B. Braun Medical
11. Corrective Action for Dimension Clinical Chemistry System - Hemoglobin A1c Flex Reagent…
12. Recall for the product Single-Use Trocar, mtp-medical technical promotion GmbH
13. Safety information for the ATP Software in devices for physical exercise (Genius Eco and…
14. Urgent Field Safety Notice for Leica ASP6025 by Leica Biosystems Nussloch GmbH
15. Urgent field safety notice for CADstream, Merge Healthcare
16. Urgent Field Safety Notice for Verbindungsschläuche Trichter Fingertip by Extrudan S.. z…
17. Urgent field safety notice for CADstream versions earlier than 5.2.6, Merge Healthcare
18. Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.
19. Recall of OneTouch Zoom Pro Diabetes Management Software, Lifescan
20. Urgent Field Safety Notice for Prestige II, Prestige VH, Prestige SI, Prestilix 1600X…
21. Urgent Field Safety Notice for Eye Station and Eye Care PACS, Merge Healthcare
22. Recall of Trident Constrained Liner Impactor Tips, Stryker Orthopaedics
23. Urgent Field Safety Notice for Tristel Rinse Wipe by Tristel Solutions Ltd
24. Urgent Field Safety Notice for Analyzer (software) for FluoroType HSV VER 1.0 by Hain…
25. Urgent field safety notice for ActiGait Implantable drop foot stimulator, Neurodan A/S
26. Urgent Field Safety Notice for Surgiwand II Auto Suture Suction and Irrigation Device 5mm…
27. Urgent Field Safety Notice for Infinity Central Station CPU by Drägerwerk AG & Co. KGaA
28. Urgent field safety notice for NIM Standard / Contact Reinforced EMG Endotracheal Tubes…
29. Urgent Field Safety Notice for BD PosiFlush XS Syringe 0.9% Sodium Chloride (0.9% NaCl) 10…
30. Corrective action for HemosIL AcuStar HIT-Ab(PF4-H), Instrumentation Laboratory
31. Artiset HD SN HC
32. Urgent Field Safety Notice for Micro Targeting Drive System by FHC Inc.
33. Urgent Field Safety Notice for PENTAX Medical Auto Leakage Tester SHA-P6 by HOYA Corp…
34. Lot Recall for Rüsch Steel Guidewires, Teleflex
35. Urgent field safety notice for ADVIA chemistry systems / Theophylline_2 (THEO_2) reagent…
36. Quidel Triage TOX Drug Screen Control 1
37. SIGMA HP PFJ Cemented Trochlear Implants
38. Stryker Trevo XP ProVue Retriever - tagasikutsumine, juhtme mõranemine
39. Recall for the ALFApump System, Sequana Medical
40. Recall for AIA-PACK ß HCG Calibrator Set, TOSOH Bioscience
41. Urgent Field Safety Notice for Vermed by Nissha Medical Technologies SAS
42. Corrective action for BBL MGIT Mycobacteria Growth Indicator Tubes, Becton Dickinson
43. Urgent Field Safety Notice for Vessel Sealer Extend; SynchroSeal by Intuitive Surgical…
44. Single-patient use drills for NobelReplace, Guided Start Drills/Counterbores and Guided…
45. Safety Notice for the EkoSonic MACH4 Endovascular Device, EKOS Corporation
46. Lot Recall of the product Endobon Xenograft Granules 0,5ml, Biomet 3i/ Biomet France
47. Korrekturmaßnahme für Control Unit TSM und Control Unit TSM 7900MT, Roche
48. Replacement of Vertical Carriage and SID Chain Wheels on Essenta DR Compact X-ray system…
49. C-arm inspection required on certain Essenta DR X-ray systems, Philips Medical Systems
50. Safety Information concerning the IPP-ON® Interphalangeal implantat holder, Newdeal SAS
51. Urgent Field Safety Notice for CARDIOVIT CS-104 by Schiller AG
52. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
53. Recall of one lot of the Accuris ™ Tibial Insert Trial MED/LG 11mm, Smith & Nephew
54. Recall of the Cortex Screw, DePuy Synthes
55. Safety Notice concerning Digital Accelerators, Elekta
56. Corrective action for the Nelaton and Nelaton Robinson Catheters, Teleflex Medical
57. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
58. Recall of Triathlon Femoral, Scorpio Femoral, Restoration Wedge Augments, Stryker
59. Lot Recall of the ECCO Silicone, ECCO med premium, Eyesky Silikon and privatelabel SiHy…
60. Urgent Field Safety Notice for cobas SARS-CoV-2 & Influenza A/B by Roche Molecular…
61. Urgent Field Safety Notice for Prismaflex Sets by GAMBRO DASCO FR
62. Urgent Field Safety Notice for Prismaflex Sets by GAMBRO DASCO FR
63. Urgent Field Safety Notice for MARS Treatment Kit by Gambro Lundia AB
64. Urgent Safety Notice / Recall for Level-1 Normothermic IV sets and Hotline blood and IV…
65. Urgent Safety Notice for Affinity® Four Birthing Bed, Hill Rom
66. Corrective action for the Sample Probe Cable for use with the UniCel DxI Family of…
67. Urgent field safety notice for RayStation 3.0 / 3.5 / 4.0 / 4.5 / 4.7 / 5, RaySearch…
68. Corrective action for the product Rotavirus Positive Control, Coris BioConcept
69. Corrective action for RUSSKA Rollator Standard and Rollator Aluminium, Ludwig Bertram GmbH
70. Urgent Field Safety Notice for BeGraft Coronary Stent Graft System by Bentley InnoMed GmbH
71. Recall for the products PlasCure06® and SelectiCure H19®, Membrana GmbH
72. Safety Notice for the the patient hoists model aks-foldy and aks-torneo, aks GmbH
73. Urgent field safety notice for Guide Sleeve yellow for TFNA, Synthes GmbH / DePuy Synthes
74. Lot recall of S100A1 (EP184) Rabbit Monoclonal Antibody, Cell Marque / Medac GmbH
75. Urgent Field Safety Notice for MitraClip NTR/XTR by Abbott Vascular Evalve Inc.
76. Urgent Field Safety Notice for BVI OPHTHALMIC FLUID CONTROL SPONGES by Beaver-Visitec…
77. Corrective action on Electrosurgical System Generators ESG-100, Celon AG medical…
78. Urgent field safety notice for TrueBeam Radiotherapy Delivery System with AlignRT, Vision…
79. Recall for the DA360 Knee system, Biomet
80. Urgent Field Safety Notice for Advanta V12 Covered Stent by Atrium Medical Corporation…
81. Recall of all lots for the DUET TRS Universal Straight und Articulating Single Use Loading…
82. Urgent Field Safety Notice for Patient Monitor by Edan Instruments, Inc.
83. Recall of Sengstaken tubes and correlating guide wires, Teleflex
84. Urgent field safety notice for Progressa Bed System with European (OIML) Version Scale…
85. Corrective Action Persona Knee System, Zimmer
86. Urgent Field Safety Notice for Atellica CH Diluent by Siemens Healthcare Diagnostics Inc…
87. CADD-Solis Ambulatory Infusion Pump
88. Urgent Field Safety Notice for LINK Schlittenprothese, Femurkomponenten, Tiviaplateaus by…
89. Urgent Safety Notice for Puritan Bennett™ 840 Ventilator, Covidien
90. Lot recall of Lenscare SH-System Monatslinsen (monthly lens), 4CARE AG
91. Urgent Field Safety Notice for Olea Sphere V3.0 IFU by OLEA MEDICAL S.A.S
92. Safety Information / Recall for the reagent Calcium CPC FS, Dia Sys Diagnostic Systems
93. Customer Safety Advisory Notice for Symbia S and T Series camera systems, Siemens AG…
94. Urgent Field Safety Notice for LIFECODES PF4 IgG and LIFECODES PF4 Enhanced by immucor GTI…
95. Corrective action for Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL), Siemens…
96. Urgent Safety Notice for Riata and Riata ST silicone insulated defibrillation leads, St…
97. Corrective action for NephroCheck Liquid Control, Astute Medical
98. Urgent Field Safety Notice for proSA Valve/ proSA Shuntsystem by Christoph Miethke GmbH &…
99. Safety Notice for the Pinnacle3 Radiation Therapy Planning System Version 9.0, 9.2 9.4…
100. Urgent Field Safety Notice for Cell Observer S., DirectFRAP, Laser TIRF by Carl Zeiss…
101. Lot Recall for the device Cemento Plus, Optimed
102. Lot Recall for the “Achsstielknie” prosthesis, AQ Implants GmbH
103. Lot Recall of the NX3 Try-In Gel, KERR
104. Urgent field safety notice for Surgical microscope HS Hi-R 1000 and HS Hi-R 700 in…
105. Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
106. Safety Notice for LifeCare 4200 PCA Infusion System, Hospira Inc.
107. Corrective action for Belzer UW® Cold Storage Solution, Bridge to Life (Europe) Ltd.
108. Urgent field safety notice for Stratus CS / CS 200 Acute Care Diagnostics System, Siemens…
109. Urgent Field Safety Notice for Xenform - Uphold - Polyform - Pinnacle by Boston Scientific…
110. Urgent Field Safety Notice for ISLEEVE 14F by Boston Scientific Corporation Marlborough
111. !
112. Urgent Field Safety Notice for Filter/HME TwinStar by Drägerwerk AG & Co. KGaA
113. Safety Notice for LIFE 18™ apheresis system, Miltenyi Biotec
114. Urgent Field Safety Notice for Diagnostic Ultrasound System by Toshiba Medical Systems…
115. SWISS optio jetflow
116. Safety Notice for STERRAD® 200, ASP (Advanced Sterilization Products)
117. Urgent Field Safety Notice for Liquid Assayed Specific Protein Controls by Randox…
118. Urgent Field Safety Notice for AM12M Acquisition Module by Welch Allyn Inc.
119. Recall of the Magstim 90mm High Power Coil, Magstim Company Limited
120. Urgent Field Safety Notice for syngo Imaging, syngo.plaza, syngo Dynamics, syngo Imaging…
121. Urgent Safety Notice for the Obalon Inflation System, Obalon Therapeutics, Inc.
122. Lot recall for Vancomycin Calibrators (Lot-No. 59391741), ThermoFisher
123. Urgent Field Safety Notice for MicroVue DPD EIA by Quidel Corporation Athens
124. Recall for Screw Modules („Screw Caddy“), Medtronic
125. Urgent Field Safety Notice for Artis icono by Siemens Healthcare GmbH Advanced Therapies
126. Safety Notice for 4D Structure Merge Tool Option in Eclipse Release 8.5-10 with 4D…
127. Safety Information for the PARACHUTE Implant System, CardioKinetix Incorporated
128. Corrective Action for ABX PENTRA ML, HORIBA
129. Urgent Field Safety Notice for LumiraDx Platform Instrument V5E by LumiraDx UK Ltd
130. Urgent Field Safety Notice for Cardia Ultraseal Left Atrial Appendage Closure Device by…
131. Urgent Field Safety Notice for Centricity Critical Care by GE Healthcare
132. Urgent Field Safety Notice for CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM by Aesculap AG
133. EnCor Biopsy Probes
134. 56d82153-7edd-32c6-e162-7064eef8eaa4
135. RayStation
136. Urgent Safety Notice for the Aeroneb, Pro, Solo, USB and NIVO Neboliser Systems, Aerogen…
137. Urgent Field Safety Notice for Kwart Retro-Inject Ureteral Stent Set / Salle…
138. Corrective Action for ADVIA Centaur and ADVIA Centaur XP, Siemens
139. Recall for Comfort Shield® Barrier Cream Cloths, Sage Products LLC
140. Batch recall of Perfusor Line, B. Braun Melsungen AG
141. Safety Notice for elastomeric infusion pumps INfusor, FOLfusor and Intermate, Baxter
142. Corrective action for the MetaVision® Suite, Clinical Information System - version 5.47…
143. Urgent field safety notice for HEALAFLOW, APTISSEN S.A.
144. Urgent Field Safety Notice for Alvarado Knee Holder by Zimmer Orthopaedic Surgical…
145. Recall of two lots of the Taperloc Femoral Stem, Biomet UK Ltd.
146. Field safety notice for slings (produced for ProLift S222 sitto-stand hoist), Novacare
147. Safety Notice concerning Revolution XR/d X-ray Systems, GE Healthcare
148. Lot Recall for Dimension Vista Cardiac Troponin I Calibrator (KC 678), Siemens Healthcare…
149. Corrective action for the eXpert DC Intraoral X-ray System, Gendex Dental Systems
150. Urgent field safety notice for cobas b 123 <3> / <4> POC system, Roche Diagnostics GmbH
151. Urgent Field Safety Notice for R3 Acetabular Shell by Smith & Nephew, Inc.
152. Safety Information for the SUPER TORQUE® Angiographic Catheter with marker band, Cordis
153. Lot Recall for the RX Accunet Embolic Protection System, Abbott Vascular
154. Safety Corrective action for the femoral neck component, MicroPort Orthopedics
155. Urgent Field Safety Notice for Creatinine PAP FS by DiaSys Diagnostic Systems GmbH
156. Safety Notice for Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore, Philips…
157. Urgent Field Safety Notice for Certain Covidien Procedure Packs containing BD PlastipakT…
158. Urgent Field Safety Notice for Cirq Arm System 2.0 by Brainlab AG
159. IFU upgrade of the MitraClip System, Abbott Vascular
160. Safety Notice for ImmunoCAP Allergen f14 (Soybean), Phadia AB
161. Urgent field safety notice for CONSERVE Shell, DYNASTY Metal Liner, PROCOTYL Metal Liner…
162. Urgent Field Safety Notice for twinSys impactor with offset by Mathys AG Bettlach
163. Urgent Field Safety Notice for Component Neuromonitoring System by Moberg Research, Inc.
164. Urgent Field Safety Notice for WiSE CRT Electrode and Delivery Catheter by EBR Systems…
165. Safety Notice concerning MammoDiagnost DR X-ray systems, Philips
166. Urgent Field Safety Notice for SpeedSurg Steuereinheit by Spiggle & Theis Medizintechnik…
167. Urgent Field Safety Notice for SPECT E.CAM, SPECT Symbia, SPECT MI, PET Biograph, PET…
168. Safety Notice for DigitalDiagnost Release 3, Philips
169. Urgent Field Safety Notice for VARIPULSE Bi-Directional Catheter by Biosense Webster Inc
170. Corrective action for the Oxoid Listeria Latex Kit, Thermo Fisher Scientific
171. Rusch One-lumen bronchial tube, right
172. Urgent Field Safety Notice for Aortic Arch Cannula by Sorin Group USA, Inc.
173. Safety Notice for the Volcano s5/s5i™ Imaging System, Volcano
174. Urgent field safety notice for Ultrastop pro med., MoNo chem-pharm Produkte GmbH
175. Additional Information about the Lot Recall of Creatinine (CREA) Flex reagent cartridges…
176. Urgent Field Safety Notice for ABL80 FLEX/CO-OX by Radiometer Medical ApS
177. Urgent Field Safety Notice for MR systems with Twinspeed by GE Medical Systems, LLC
178. Recall for Osseotite® Tapered Certain® Implants, BIOMET 3i
179. Recall for ASSISTO arm-systems, GEOMED Medizin-Technik GmbH
180. Lots recall of 200 mm EverFlexTM, ev3 Incorporated
181. Corrective action of the S5 Perfusion System, Sorin
182. Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter…
183. Batch Recall for Screw-vent®/Blank Screwvent/Abutment Blanks, ELOS Medtech
184. Urgent Field Safety Notice for Artis systems with 19 inch Live Display, Siemens Healthcare…
185. Urgent Field Safety Notice for Milling Drill D1.5mm by Alpha- Bio Tec. Ltd.
186. Lot Recall of 1 DAY ACUVUE MOIST contact lenses, Johnson & Johnson Vision Care
187. Corrective action for Single-width Airway Module E-miniC and Extension Modules N-FC…
188. Urgent Field Safety Notice for ReWalk Personal by ReWalk Robotics Ltd.
189. Urgent Field Safety Notice for Bilirubin und Creatinine Tests (Bilirubin Auto Direct…
190. Urgent Field Safety Notice for GTS Rasp Size +7 / GTS OHST Rasp Size +7 by Biomet France…
191. Urgent Safety Notice for Neopterin EIA, Brahms GmbH
192. Urgent Safety Notice for the Vision Sciences® Battery Charger and Rechargeable Lithium-Ion…
193. Aisys CS2
194. Safety Notice for the ClinActiv® Therapy Surface, Hill-Rom
195. Urgent Field Safety Notice for Kimal Procedure Packs by Kimal Plc
196. Urgent Field Safety Notice for CF-Y0067-L by Olympus Medical Systems Corp.
197. Urgent Field Safety Notice for Einmal-Biopsie-Zange by Health Sun LTD
198. Recall for the emergency ventilation scarf Aerobag BT2-FMS7x7-B, HUM GmbH
199. Safety Notice concerning the Terumo® Advanced Perfusion System 1 - Central Control…
200. Corrective action for Dimension Clinical Chemistry Systems LOCI Cardiac Troponin I…
201. Lot Recall for the SURGIFLO Hemostatic Matrix Kit, ETHICON
202. Urgent field safety notice for Roccia MultiLIF Probe 13x34 mm 5° Lor., Silony Medical
203. Lot / batch recall of Autofuser AFMP-2CA / AFMC-10 / AFSC4, OMT GmbH & Co. KG
204. Lot Recall of vascular catheters, Applied Medical
205. Lot recall of Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard…
206. Lot Recall for the Multifly needle, Sarstedt AG
207. Recall of EMBOL-X Glide Protection Systems, Edwards Lifesciences
208. Urgent Field Safety Notice for ABL90 Flex by Radiometer Medical ApS
209. Corrective action for BRAHMS TRAK human Kryptor, Thermo Fisher
210. Recall for Brainlab Disposable Reflective Marker Spheres (DRMS), Brainlab AG
211. Urgent Field Safety Notice for cobas m 511 integrated hematology analyzer by Roche…
212. Safety Notice for ISE Ref-Valves for AU400, AU640, AU2700 and AU5400 Chemistry Analysers…
213. Urgent Field Safety Notice for Restoration Anatomic Shell by Howmedica Osteonics…
214. Safety Notice for the Cios Alpha mobile C-arm x-ray System, Siemens Healthcare
215. Urgent Field Safety Notice for Sensis systems by Siemens Healthcare GmbH; Business Area…
216. Urgent field safety notice for VIDAS Estradiol II (ref. 30431), bioMérieux SA
217. Urgent Field Safety Notice for Straumann TempImplant ø 2.0mm, L 12.0mm, Ti by Institut…
218. Urgent Field Safety Notice for ARCHITECT iGentamicin Reagent Kit by Abbott GmbH & Co.KG
219. Urgent field safety notice for TrueBeam Radiotherapy Delivery System with AlignRT, Varian…
220. Urgent Safety Notice for the VeriSuite 1.8, MEDCOM GmbH
221. Batch recall of Optiplug® Cement Restrictors, Integra LifeSciences
222. Urgent Field Safety Notice for SCHILLER medilog DARWIN by Schiller AG
223. Urgent field safety notice for APM 440X, Novacare GmbH
224. Urgent Field Safety Notice for EnCor Breast Biopsy Probe by SenoRx, Inc.
225. Urgent Field Safety Notice for SCOUT Guide and SCOUT CHECK Handpiece by Merit Medical…
226. Corrective action for the LX3 Microscope Floor Stand, Alcon Laboratories Inc.
227. Corrective action for ADVIA Centaur systems Calibrator B and ADVIA Centaur FSH assay on…
228. Urgent Safety Notice for GE General Purpose Temperature Probe, GE Healthcare
229. Lot recall of LK018.OPT Optilite Freelite Lambda Kit, The Binding Site Group Ltd.
230. Urgent Field Safety Notice for ARROW Mehrlumen-ZVK by Arrow International Inc.
231. Urgent field safety notice for VASCU-GUARD Peripheral Vascular Patch, Baxter Healthcare…
232. Urgent Field Safety Notice for NO-Applikationsgerät by EKU ELEKTRONIK GMBH
233. Extended Recall for the XIA/XIA3/XIA Elegance/Mantis Redux Torque Wrenches, Stryker
234. Safety Notice for the FrameArray Module (of the Optical Guidance Platform), Varian medical…
235. Urgent Field Safety Notice for Transpac IT w/91 INCH (232 CM), 3 ML/HR Macrodr by ICU…
236. Patterson Walking Sticks - 404 Model
237. Roche BILT3, IGM-2, LACT2 - TÄIENDATUD sisemised koosmõjud, tarkvarapakett uuendatakse
238. Urgent Field Safety Notice for Oxoid CT0159B by Remel Europe. Part of Thermo Fisher…
239. Urgent Field Safety Notice for MAHURKAR and Argyle Acute Hemodialysis Catheters by…
240. Urgent Field Safety Notice for I.V extension set by ICU Medical, Inc.(alt)
241. Urgent field safety notice for MylabTwice, Esaote
242. Urgent Field Safety Notice for Transpac IT by ICU Medical, Inc.(alt)
243. Safety Notice for the (AMO) STAR Excimer Laser System, Abbott Medical Optics, Inc.
244. Urgent field safety notice for Adapter Colibri / Electric Pen Drive and Adapter small…
245. Recall for LightMix Kit HFE, TIB MOLBIOL
246. Urgent field safety notice for BCU Blood Culture Cartridge Set, Curetis GmbH
247. Urgent Safety Notice for certain Medrad® Mark 7 Arterion® Injection Systems, Bayer Medical…
248. AlloSeq HCT Software
249. Urgent field safety notice for G-scan Brio Magnetic Resonance System, Esaote
250. Urgent Medical Device Correction Notification for the NicoletOne Software v5.94, Natus…
251. Urgent Field Safety Notice for pMTA Accu2i Applicator by AngioDynamics Inc.
252. Urgent field safety notice for STIMPOD NMS410 / NMS450 Nerve Stimulator, Xavant Technology…
253. Safety Notice for Invasive Blood Pressure Cable, GE Healthcare
254. Recall for EXTRON external wrist fixator, tantum AG
255. Corrective Action for GSP, PerkinElmer
256. Safety Notice concerning the Flex Large 4 coil for Magnetom Skyra, Verio, Spectra and…
257. Urgent Safety Notice for the optimys® Opening Broach bent, Mathys AG
258. Safety Notice for the Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max…
259. Lot Recall of an infusion extension line named “T-connector Luer-Lock”, Hospira
260. Lot Recall for the Twinplusdrain drainage catheter, Peter Pflugbeil GmbH
261. Urgent Field Safety Notice for Mentype MycoDermQS Lateral Flow by Biotype Diagnostic GmbH
262. Urgent Field Safety Notice for ETT Set with cuffed Murphy ETT intubation by Guangzhou AMK…
263. Urgent Safety Notice for the cobas b 121, cobas b 221 systems, Roche Diagnostics…
264. Urgent Field Safety Notice for NEOLISA Chromogranin A by Euro Diagnostica AB
265. Urgent Field Safety Notice for ARCHITECT c4000 / c8000 / c16000 Mixer by Abbott…
266. Safety Information for the Autostainer Link 48 instrument, Dako North America, Inc.
267. Urgent Field Safety Notice for Intravenous line stopcock by Smiths Medical ASD, Inc…
268. Lot recall of IBS-PEEK TLIF II, Peter Brehm GmbH
269. Urgent field safety notice for Transcatheter Aortic Valve System, Direct Flow Medical Inc.
270. Urgent Field Safety Notice for Oxoid PO1258E by Thermo Fisher Scientific Microbiology…
271. Recall of SAGB QuickClose Swedish Adjustable Gastric Band, Ethicon
272. Lot recall of NucliSENS easyMAG, bioMérieux SA
273. Urgent Field Safety Notice for Atellica IM/ADVIA Centaur Enhanced Estradiol (eE2) by…
274. Safety Notice for the Brainlab Micro-Multileaf Collimator (MLC), Brainlab AG
275. Potential safety issue of ViewPoint 6, GE Healthcare
276. Urgent field safety notice for TANGO infinity, Bio-Rad Medical Diagnostics GmbH
277. Urgent Field Safety Notice for ARCHITECT S.A. Myoglobin Calibrators by Abbott Laboratories…
278. Safety Information for the device CyberKnife Systems with the Lung Optimized Treatment…
279. Safety Notice/Update to the IFU for the Siesta i TS machine, DAMECA A/S
280. Urgent Field Safety Notice for Artis, X-Workplace, Sensis and ARCADIS Systems by Siemens…
281. Lot recall of 2.3 mm Tapered Router, Stryker Instruments
282. Urgent Field Safety Notice for syngo Workflow MLR by Siemens AG, Medical Solutions, SYNGO…
283. Urgent Field Safety Notice for Pneumograph, chest, NM, 3160 _ 94023 by Philips Medical…
284. Corrective action for the UniCel DxH 800 Coulter Cellular Analysis System, Beckman Coulter
285. Urgent Field Safety Notice for SPRUNGRESERVOIR , Burrhole Reservoir by Christoph Miethke…
286. Urgent Field Safety Notice for M.Scio by Christoph Miethke GmbH & Co. KG
287. Urgent Field Safety Notice for LASERFASER Ø 272µM EINWEG by Richard Wolf GmbH
288. Urgent Field Safety Notice for DIVA 24 Inc. Widescreen LCD Touch Display by Philips…
289. Recall for the Link® Endo-Modell® Tibial Plateau Sets” and “Link® Endo-Modell® Replacement…
290. Urgent Field Safety Notice for Punktionsschleuse by Somatex Medical Technologies GmbH /…
291. Batch recall of Zestica fertility applicator, Bescot Healthcare UK Ltd.
292. Urgent Field Safety Notice for RNeasy DSP FFPE Kit by QIAGEN GmbH
293. Urgent Field Safety Notice for BD BBL Gram Crystal Violet 250mL & Grain Stain Kit by…
294. Safety Notice for the Centricity PACS IW with Universal Viewer Version 5.0 and Centricity…
295. Urgent Field Safety Notice for BRAHMS anti-Tgn RIA by Brahms GmbH, part of Thermofisher…
296. a8e6616b-eb3c-cd05-d56e-886a2ad67869
297. Urgent Field Safety Notice for JenaValve TAVI System by JenaValve Technology GmbH
298. Corrective action for the Posterior Fluidics Module of the Stellaris PC Vision system…
299. Urgent Field Safety Notice for SCORE 6 by CareDx AB
300. Urgent Field Safety Notice for syngo.via RT Image Suite by Siemens Healthcare GmbH, SYNGO…
301. Urgent Field Safety Notice for Thyreoidal Peroxidase-Ab (TPO-Ab) by Demeditec Diagnostics…
302. Urgent Field Safety Notice for ThermaCare by Pfizer Consumer Health Care
303. Safety Notice for Vitrea and Vitrea Enterprise Suite, Vital Images
304. Urgent Field Safety Notice for GAMMA SUPII by CLERAD (CLERmont RAyonnement Détection)
305. Recall for the TPHA 100 Kit, Biomerieux
306. Safety Notice concerning the purification unit for medical air EcoPharm Tower, Dräger
307. Field Safety Notice regarding power cords supplied with certain models of AIRVO PT100 and…
308. Urgent field safety notice for OR table column TruSystem 7500 / 5500, OR table column…
309. Recall of ACROBAT, ACROBAT V, ACROBAT SUV, XPOS 3 and XPOs 4, Maquet
310. Urgent Safety Notice for Actifuse, BAXTER
311. Urgent Field Safety Notice for Nicolet Elite Probes by Natus Neurological Incorporated
312. Recall for the Target Coils, Stryker Neurovascular
313. Urgent Field Safety Notice for MOSAIQ by IMPAC Medical Systems, Inc.
314. Field safety corrective action on electrosurgical unit ESG-400, Olympus Winter & Ibe GmbH
315. Recall for the Gliding Nail GN Blade Handle, Smith & Nephew Orthopaedics
316. Safety Notice concerning use of Oncentra MasterPlan and Oncentra External Beam, Nucletron
317. Safety Notice for Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and…
318. Urgent Safety Notice for the product VarioFit® (cemented), aap Implantate AG
319. Urgent field safety notice for Triathlon Modular Handle, Stryker Orthopaedics
320. Urgent Field Safety Notice for HITACHI ARIETTA Prologue by Hitachi, Ltd.
321. Urgent Field Safety Notice for Leksell Stereotactic System by Elekta Solutions AB
322. Recall of the Universal Set with MSC products, Mölnlycke Health Care AB
323. HAMILTON-G5 / S1
324. Potential for gantry collisions of Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™…
325. Urgent Field Safety Notice for Artis zee/Q/Q.zen systems by Siemens Healthcare GmbH…
326. Recall of the device NL8600401 - Non-sterile stainless steel stepdown connector, Integra…
327. Urgent field safety notice for MultiQuant MD, AB Sciex
328. Urgent Field Safety Notice for Sharesource Connectivity Platform for use with the by…
329. Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland…
330. Safety Notice/Recall for Mini Crosser M1, Mini Crosser A/S
331. Urgent Field Safety Notice for Vanguard Complete Knee System by Biomet Orthopedics, LLC
332. Urgent Field Safety Notice for HexaPOD evo RT System / Medical Intelligence Mediz by…
333. Urgent Field Safety Notice for Flowstar by Medical Measurement Systems B.V.
334. Urgent Field Safety Notice for TriageHF Data Calculation Module (DCM) by Medtronic Inc
335. Corrective action for the MEDUMAT Transport ventilator, WEINMANN Emergency Medical…
336. Probes for organ harvesting
337. Aquarius
338. Urgent field safety notice for ArcticSun ArcticGel Neonatal Pad, C.R. Bard Inc. /…
339. Urgent Field Safety Notice for PASCAL Transcatheter Mitral Valve Repair System by Edwards…
340. Corrective action for the iChemVELOCITY Urine Chemistry Strips, Iris International
341. Urgent Field Safety Notice for single use cuffs for tourniquet application by Ulrich GmbH…
342. Malfunction of modulator reverse diode, Elekta
343. Safety Notice for the FerX-ELLA Esophageal Stent Boubella and FerX-ELLA Esophageal Stent…
344. Urgent Safety Notice for Pronefro Therapy Chairs, Pronefro - Produtos Nefrológicos, S.A.
345. Corrective action for the syngo RT Therapist™ and the Control Console with the Digital…
346. Corrective action for the syngo RT Oncologist™ with software version 4.2.X or 4.3.X…
347. Safety Notice for the METHA Titanium Cone Adapter (Neck), Aesculap AG
348. HomeChoice PRO Automated Peritoneal Dialysis Cycler, 115 V
349. Medium Ratcheting Driver Handles
350. Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope…
351. Urgent Field Safety Notice for AAA Wire WiTRAC by EPflex Feinwerktechnik GmbH
352. Urgent Field Safety Notice for Mobile S., Ergothan by Medical Service GmbH
353. Recall of INRatio and INRatio 2 PT / INR Monitoring System, Alere
354. Urgent Field Safety Notice for Cardiosave Hybrid Intra-Aortic Balloon Pump by Datascope…
355. Safety Notice for the Integrated Module Housing, Spacelabs Healthcare
356. Urgent Field Safety Notice for SDMS (SenTec Digital Monitoring System) by SenTec AG
357. Urgent Field Safety Notice for Diathermy Suction Devices by Eakin Surgical Limited
358. Urgent Field Safety Notice for Trifecta Valve, Trifecta GT Valve by S.. Jude Medical…
359. Urgent Field Safety Notice for POWER DRILL TORQUE LIMITER by Orthofix SRL
360. Urgent Field Safety Notice for Epidummy by Episurf Operations AB
361. Urgent Field Safety Notice for CopiOs Cancellous Particulate Xenograft by Tutogen Medical…
362. Urgent Field Safety Notice for Epiguide by Episurf Operations AB
363. Urgent Field Safety Notice for TraumaDiagnost by Philips Medical Systems DMC GmbH
364. Urgent field safety notice for Air Dermatome II, Zimmer Biomet Surgical
365. Urgent Field Safety Notice for Equinox Relieve, Equinox Advantage by O-Two Medical…
366. Lot Recall of the product Excite F DSC, Ivoclar Vivadent AG
367. Safety Notice for Precision 500D, Legacy, RFX and SFX X-ray imaging systems, GE Healthcare
368. Urgent field safety notice for MOSAIQ, Elekta AB / IMPAC Medical Systems Inc.
369. Urgent Field Safety Notice for Div. Produkte by Immundiagnostik AG
370. Boston Scientific Guider Softip XF Guide catheters - tagasikutsumine, otsaku kaar vale…
371. Safety Notice for the Sorin S5/C5 Perfusion System, Sorin Group
372. Recall for the software application card used in the 8840 N’Vision clinician programmer…
373. DS EVOLUTION CEMENTLESS
374. Recall of the Irrigation Tube Sets, DePuy Synthes
375. Safety Notice concerning the Hamilton-C2 ventilator, Hamilton Medical
376. Corrective action for RapidPoint 400 Series, RapidPoint 500 and RapidLab 1200 Series…
377. Corrective Action for Dade Actin FSL Activated PTT Reagent, Siemens
378. Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter…
379. Safety Notice for the Bright View XCT Imaging System, Philips Healthcare
380. Urgent Field Safety Notice for Elecsys Troponin I / Troponin I S.A., Elecsys proBNP II /…
381. X-Ray Gauze Swabs
382. Corrective action for the Lightspeed CT scanner or Discovery ST and Discovery LS PET CT…
383. Urgent Field Safety Notice for Intellis Recharger by Medtronic Inc
384. Corrective action for COULTER LH 750-, 780-, 500- Analyzer, Beckman Coulter
385. Recall for the Terumo Syringe - 30ml Luer Lock/ Centric, Terumo Europe NV
386. Recall for the Easypump II, B. Braun Melsungen AG
387. Urgent Field Safety Notice for AFX EndoVascular AAA System by Endologix International…
388. Medical Device Labelling Correction to TomoFix Medial High Tibia Plate, DePuy Synthes/…
389. Urgent Safety Notice for the chromID™ S. aureus range products, bioMérieux
390. Recall of Trial Insertation Instrument ME020R, Aesulap AG
391. Urgent Field Safety Notice for Video Processor/Illuminator (VPI) by Novadaq Technologies…
392. Corrective action for the Enteral Syringe Pumps P500, P700 and P900, Medicina Ltd.
393. Urgent Field Safety Notice for ReWalk Personal by ReWalk Robotics Ltd.
394. Corrective action for the Anterior/Supine Rasp Handles, Zimmer, Inc.
395. Safety issues on AW Server product, GE Healthcare
396. Lot recall of Covidien Valleylab Laparoscopic Electrodes, Medtronic
397. Urgent Field Safety Notice for EVIS LUCERA DUODENOVIDEOSCOPE by Olympus Medical Systems…
398. Urgent field safety notice for LIAISON Estradiol II Gen, DiaSorin Inc. US
399. Corrective action for the Previ Isola System, Biomerieux
400. Urgent Field Safety Notice for Werber Countersink Cannulated for micro CBS screws by…
401. Safety Notice for the Mobilett Mira, Siemens Healthcare
402. Corrective action for RapiD 20 E, Biomerieux
403. Recall of Breeze C Scooters, Afikim Electric Vehicles
404. Recall of several lots of the LifeStent Solo Vascular Stent System. The recall is only for…
405. Urgent field safety notice for AXIOM Artis, Artis zee and Artis Q/Q.zen systems, Siemens…
406. Urgent Field Safety Notice for EMU40 by Natus Medical Incorporated DBA Excel-Tech Ltd…
407. Safety Notice for AXIS and IRIX SPECT Systems, Philips
408. Urgent Field Safety Notice for QuickFlap, Neuro Implants by Stryker Leibinger GmbH & Co…
409. Safety Notice for the Robotvario system, Miele & Cie.
410. Lot recall of INTERCEPT Plasma system, Cerus Corporation
411. Field Safety Notice for GSI Viewer on Advantage Worksation products, GE Healthcare
412. Corrective action for the CARESCAPE respiratory modules, the Airway Gas Option and their…
413. Corrective action for the GAP Endo-Exo Medullary System / Nail Driver, Pega Medical
414. Urgent field safety notice for Ganestin reagent, DiaSys Deutschland Vertriebs-GmbH
415. Urgent Field Safety Notice for AltoSa-XL-Gemini Balloon Catheter by Andratec GmbH
416. Recall for the Spiralok Suture Anchors, DEPUY MITEK
417. Urgent field safety notice for container washers PG 8821, PG 8822, PG 8825, PG 8830, PG…
418. Urgent Field Safety Notice for Access-9 and AccessPLUS Hemostasis Valves by Merit Medical…
419. Urgent Field Safety Notice for 20/30 INDEFLATORTM, INDEFLATORTM Plus 30 and Priority Packs…
420. Corrective action for VITROS® 4600 Chemistry Systems & VITROS® 5600 Integrated Systems…
421. Safety Notice for the Centricity RIS-i system, GE Healthcare
422. Urgent Field Safety Notice for Tubing Sets for Hemodialysis / DORA by Bain Medical…
423. Recall for the VariAx Compression Plates, STRYKER
424. Urgent Field Safety Notice for Mammomat Revelation by Siemens Healthcare GmbH Advanced…
425. Urgent Field Safety Notice for T2 Locking Screws, Compression Screws, End Caps, Gamma3 End…
426. Recall of mobile pneumatic drivers Freedom Driver System, Syncardia Systems Inc.
427. Safety Notice for Reusable Cranial Perforators, ACRA-CUT Inc.
428. Urgent Field Safety Notice for Elekta Unity by Elekta Ltd
429. PG 8536
430. Urgent Field Safety Notice for AXIOM Aristos MX/VX by Siemens Healthcare GmbH, X-Ray…
431. Potential hazard associated with use of NIBP pump inside of monitor module, Spacelabs…
432. Urgent Safety Notice for the Patient support for stitching, Philips Medical Systems
433. Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB
434. Urgent Field Safety Notice for FlowSENS by Medex SAS
435. Urgent Field Safety Notice for EMBLEM S-ICD by Boston Scientific CRM
436. Safety Notice for Agfa HealthCare IMPAX® Cardiovascular (IMPAX CV) products, Agfa…
437. Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland…
438. Urgent Field Safety Notice for Artis zee/Q/Q.zen systems by Siemens Healthcare GmbH…
439. ceb31534-771f-c23c-dc66-13417d0a7ceb
440. Urgent Field Safety Notice for Welch Allyn no.-automated blood pressure gauges by Welch…
441. Corrective action for Immulite 2000 / Immulite 2000 XPi Troponin I, Siemens
442. Lot Recall for the Persona ™ Cemented Tibia Drill, Zimmer Inc.
443. Urgent Field Safety Notice for Trauma Guide Wire by Zimmer Inc.
444. Corrective action for the da Vinci Xi™ Surgical Systems - Patient Carts, Intuitive…
445. Urgent Field Safety Notice for BBRAUN / SYRINGES / HYPODERMIC / GENERAL by B. Braun…
446. Tevdek
447. Coopers Walking Frames
448. AUGMENTIN 32mg/L PLATE, MPM-AUG32
449. ARIA Radiation Oncology System
450. Safety Notice for the Mavig Portegra 2 systems, Siemens Healthcare
451. Urgent Field Safety Notice for Access Free T3, Access Total T3, Access Free T4, Access GI…
452. Urgent Field Safety Notice for HexaPOD evo RT System / Medical Intelligence Mediz by…
453. Safety Notice for Senographe 2000D Mammography systems, GE Healthcare
454. Urgent field safety notice for G210 Incubators, K-Systems / Kivex Biotec A/S
455. Corrective action for Integrated Digital Pathology System Software, version DPS 1.1, Omnyx
456. Urgent Field Safety Notice for Altair Lifting Solutions by Human Care HC AB
457. Recall oXiris set for acute dialysis therapy, Gambro
458. Urgent field safety notice for central axis system, S.I.M.E.O.N.
459. Safety Notice for the Diagnost 94, 96 or 97 systems, Philips
460. Safety Notice for SureSigns VSi/VS2 Patient Monitors, Philips Healthcare
461. New checklist for STERRAD Boosters and Adapters before and after STERRAD sterilization…
462. Recall for the Charnley Pin Retractor & Handle Set, DePuy Synthes
463. Safety Notice for implantable pulse generators for neurostimulation Eon, Eon Mini and…
464. Corrective actions relating to KayserBett Olaf 85 manufactured from 1999 - 2004…
465. Recall of implantable pulse generators for neurostimulation Eon Mini and Brio, St. Jude…
466. Recall of controller units of implantable HeartWare VAS, HeartWare Inc.
467. Corrective action for Immulite 2000 / Immulite 2000 XPi EBV-EBNA IgG, Siemens
468. Safety Notice for the Philips Ingenuity CT, Philips
469. Urgent Field Safety Notice for MedAll PAG-960, BPro1 PAG-990, B2 PAG-880 by BIOPTRON AG
470. Recall of any remaining model 1 or model 2 bronchial clamping adapters for 1.8 mm…
471. Corrective action for the M6 supply unit, Gebrüder Martin GmbH & Co. KG - KLS Martin Group
472. Corrective Action for TANGO optimo pipetting system, BioRad
473. Corrective action of surgical lighting systems iLED and TruLight, Trumpf Medizin Systeme…
474. Corrective action for UniCel DxH 800 and 600 Coulter Cellular Analysis Systems, Beckman…
475. Urgent Field Safety Notice for Atrauma suction catheter, Stomach tube with mandrin…
476. Problem with Pinnacle³ Software Version 9.0, Philips Healthcare
477. Corrective action for Advia Chemistry Calibrator, Siemens
478. Corrective action for Coulter LH 750 and Coulter LH 780 Hematology Analyzer, Beckman…
479. Urgent Field Safety Notice for ENO/TEO/OTO/KORA 250 by MicroPort CRM S.r.l.
480. Safety Notice for the Helical Blade for TFN, SYNTHES
481. Urgent Safety Notice for Hitachi MRI Systems AIRIS Vento, AIRIS Vento LT, APERTO Eterna…
482. Urgent Field Safety Notice for QIAamp DSP Virus Kit by QIAGEN GmbH
483. Recall of several Zenith Ankle Tibial Inserts, Corin
484. Urgent Field Safety Notice for Bexen Cardio Paediatric Pads for Defibrillation by FIAB SpA
485. Urgent Field Safety Notice for Hedia Diabetes Assistant by Hedia ApS
486. Field Safety Notice concerning updated instructions for use and labelling of beds Contura…
487. Urgent Field Safety Notice for Diamantschleifinstrumente Dental by NTI Kahla GmbH Rotary…
488. Lot Recall of the Versys® Hip System Cemented Revision/Calcar Femoral Stem, Versys…
489. Urgent Field Safety Notice for Getinge 9100-Series by Getinge Disinfection AB
490. Urgent Safety Notice for the Topcon Specular Microscope model SP-1P, Topcon Corporation
491. Safety Notice for the Basin Liner within Mölnlycke ProcedurePak®, Mölnlycke Health Care
492. Safety Notice for the MAGEC® Spinal Bracing and Distraction System, Ellipse Technologies…
493. Recall of several lots of COBE® Spectra Apheresis System Disposable tubing sets FSN BCT8…
494. Lot Recall for the Flexible Drill D3,2 x 149, OHST Medical Technology
495. Urgent Field Safety Notice for Various Biomet Products by Biomet Orthopedics, LLC
496. Recall of 8-Rod Covers (Lot. No. 1104624, 1105182) due to manufacturing errors, QIAGEN