International device safety notices

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

1. Safety notice for Vagus Nerve Stimulation Leads, Cyberonics
2. Urgent Safety Notice for the product BD BBL™ CHROMagar™ MRSA II, Becton Dickinson
3. Urgent Safety Notice for the TurnPike Spiral and TurnPike Gold catheters, Vascular…
4. Medical Device Recall: NC / RC Screws for CARES Abutment, STRAUMANN
5. Urgent Field Safety Notice for Bravo pH Monitoring System and Accessories by Covidien llc
6. Change in corrective action for CA-1500 series coagulation analyzers, Sysmex
7. Urgent Field Safety Notice for SpaceOAR and SpaceOAR Vue Systems by Boston Scientific…
8. Urgent Field Safety Notice for Sage Vitrification Media Kit by CooperSurgical, Inc…
9. Important Safety Notice for the Symbia T Series and Symbia Intevo camera system, Siemens…
10. Information for Bioball Metal Heads, Merete
11. Lot Recall for Genos MC/MT Mini Distractors, GEBRÜDER MARTIN
12. Safety Notice for patient monitor BM3, Bionet Co., Ltd.
13. Field Safety Notice for the Harness Safety System, Maquet
14. Corrective action/Recall for adjustors (LLBL, LLBH) and controls (LLBC1-2) of certain lots…
15. Safety Notice for the Perimeter OCTOPUS 101, Haag-Streit International
16. Urgent Field Safety Notice for ACCESS Total T3, Thyroglobulin, Free T4, GI Monitor by…
17. Recall of one lot of the central venous catheter Premicath
18. Safety Notice for the Bluephase G2 and Bluephase 20i Polymerisation Light, Ivoclar…
19. Recall for Reflection hip, PE inlay, Smith & Nephew
20. Recall for Aneroid Sphygmomanometer Stethoscope, Wenzhou Bokang Instruments Co., Ltd
21. Löwenstein Medical GmbH & Co. KG elisa iCritical Care Ventilator - vigane häiresüsteem
22. 1cfd5da1-a15b-7287-599f-35a16ede0dd7
23. Corrective action for ADAMS A1c Calibrator 80, Arkray
24. Urgent Field Safety Notice for POLARSHEATH by Boston Scientific Corporation Marlborough
25. Recall of T2 Ankle Arthrodesis Nails, Stryker
26. Urgent Field Safety Notice for CompoStop by Fresenius Kabi Deutschland GmbH
27. Urgent field safety notice for Lumipulse G E2-III Immunareaction Cartridges, Fujirebio…
28. Urgent Field Safety Notice for Inflation Device 30 atm by ArcRoyal Ltd.
29. Urgent Field Safety Notice for NEOselect/NEOliquid - POST PCR Box (-20°C storage) by NEO…
30. Recall for ENDOPATH® Electrosurgery Probe Plus II, ETHICON
31. Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.
32. Urgent Field Safety Notice for Alinity i Processing Module by Abbott GmbH & Co. KG
33. Recall Difco Shigella Antiserum Poly Group B, Becton Dickinson
34. Recall Information on certain Navigation software applications, Stryker
35. Urgent field safety notice for StreamLAB Automation Solutions / Aptio Automation/ FlexLab…
36. Information for syngo TrueD, Siemens
37. Safety Notice for MicroMaxx and M-Turbo ultrasound systems, Sonosite
38. DiUrgent field safety notice for Quantex Digitoxin, Biokit S.A.
39. Urgent Field Safety Notice for Functional Fibrinogen Kit by Haemonetics Corporation US
40. Urgent Field Safety Notice for ROSA by Medtech SA
41. Recall of Dimension Vista LOCI Reaction Vessel, Siemens
42. Corrective action of the intraoral digital imaging plate system DIGORA Optime Type DXR-60…
43. Urgent Field Safety Notice for iChemVELOCITY Urine Chemistry Analyzer,iQ200 Urine…
44. Safety Notice concerning new reprocessing instructions for Sigmoidoscope and Anoscope…
45. Recall for cobas c 411, Roche
46. Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
47. Information for ADVIA Centaur, Siemens
48. Batch recall of Affinis Fracture, Inverse, and Short implants with Ti/CaP coating, Mathys…
49. Urgent Field Safety Notice for NEVELIA by SYMATESE SAS
50. Information for Graseby 3000 and 3100, Smiths Medical
51. Recall of gabControl Strep A Test Cards, gabmed
52. Urgent field safety notice for RayStation 5, RaySearch Laboratories AB
53. Information for the monitor units Eclipse™, Varian
54. Corrective action for the product COSEAL Surgical Sealant 2ml and 4ml, Baxter Healthcare…
55. Recall for Nexgen Tibial Baseplate, Zimmer
56. Safety Notice for EndoWrist Hot Shears™ instruments, Intuitive Surgical®
57. Safety Notice for the GH3 Lifting Hanger, Guldmann
58. Information for Laryngoscope Handle, Medida
59. Recall of Biomérieux for VITEK 2 GN
60. Safety Notice for OPERA T, PRECISION RXi-T, MERATEL, BRT-20, CLINODIGIT COMPACT, FUTURA…
61. Urgent Field Safety Notice for IRATHERM1000 by Von Ardenne Institut für Angewandte…
62. Safety Notice for Mustang walking aids, R 82 A/S
63. Corrective action for the products medi Clutch Lock and medi Modular Clutch Lock, medi…
64. Idylla EGFR Mutation Test
65. Recall for searcher-cores, Richard Wolf GmbH
66. Safety Notice for Kehr/VanKemmel T-Drainage, Coloplast
67. Field Safety Notice for customers of the Epicor LP Cardiac Ablation System
68. Safety Notice for Hemochron® Whole Blood Coagulation System, International Technidyne…
69. Recall for the swivel shower chair model Ben, Drive Medical GmbH & Co. KG
70. Recall for the Clinical Chemistry Urea Nitrogen Reagent, Abbott
71. Safety Notice for Neon Swing-Away wheelchairs, Sunrise Medical GmbH & Co. KG
72. Safety Notice for Spectra Optia Apheresis System, CaridianBCT
73. Urgent field safety notice for Quo-Test HbA1c Analyser, EKF diagnostic GmbH
74. Urgent Field Safety Notice for cobas 6800 system, cobas 8800 system by Roche Diagnostics…
75. Field Safety Notice for Navigation Headset Operator's Manual, GE Healthcare
76. Urgent field safety notice for Quantex Digitoxin, Biokit S.A. / Werfen
77. Potential misinterpretation of PCR Eleva´s mirror icon, Philips Healthcare
78. Batch recall of SimpliRED D-dimer, BBI Solutions OEM Limited
79. Urgent Field Safety Notice for N Protein Standard S.; N/T Protein Control S. by Siemens…
80. Urgent Field Safety Notice for da Vinci X and da Vinci Surgical System by Intuitive…
81. Safety Notice for the High Pressure Stopcocks, ArcRoyal
82. Information for Biophen Heparin 6, HYPHEN BioMed
83. Urgent Field Safety Notice for NavLock Tracker and associated sets and kits by Medtronic…
84. Recall for DHEA RIA Kit, Beckman Coulter
85. Safety Information for Animas Insulin Pumps, Animas Corporation
86. Urgent Safety Notice for the T-Pal Technique Guide, Synthes GmbH
87. Safety Notice: Swapped MR gradient cables, GE Healthcare
88. Safety Notice on inaccurate values of the Hematocrit / Oxygen Saturation Monitoring…
89. Corrective Action of DiaSys for one HbA1c IS, for one HbA1c FS, TruCal HbA1c liquid…
90. Corrective Action for RIA FT3, Beckman Coulter
91. Recall of Tissue Punch, DFS-Diamon GmbH
92. Recall for Dimension HM Reaction Vessels, Siemens
93. Recall for Brain Heart Infusion Broth, OXOID
94. Urgent Safety Notice for the product Calcibon, Biomet
95. Safety Notice for the device Monaco, Elekta CMS Software
96. Additional Recall for the Bioraptor, Osteoraptor and Twinfix Ultra Suture Anchors…
97. Urgent Field Safety Notice for Drill Extension by Sirona Dental Systems GmbH
98. Recall for Philips urethral catheters, Coloplast
99. Important Information for the AMPLATZER™ Septal Occluder, St. Jude
100. Safety Notice for all GE Healthcare MR systems, GE-Medical Systems
101. Urgent Safety Notice for the Bard® ARTIC SUN® Temperature Management System, Bard Medical…
102. Corrective action concerning the M6 service head, Ondal Medical Systems GmbH
103. Safety Notice/Corrective action for Leica ASP200S / Leica ASP300S, Leica Biosystems…
104. Safety Notice for Libra and Libra XP, Advanced Neuromodulation Systems
105. Recall of several lots of the silicone oil RT SIL-OL 1000, Carl Zeiss Meditech AG
106. Urgent Field Safety Notice for Soft Tip Stylet 14Fr,Sher-I-Stylet 10Fr,Sher-I-Slip Stylet…
107. Safety Notice for dental chair A-dec 200, A-dec
108. Corrective action for Dimension Vista® Creatinine (CREA), Siemens Healthcare Diagnostics
109. Urgent field safety notice for ALT OSR6X07 / Glucose-Stat OSR6X40, Beckman Coulter
110. Corrective Action for Dimension Vista HCYS Flex Reagent Cartridge, Siemens Healthcare
111. Urgent field safety notice for FLOW-i C20 / C30 / C40, Maquet Critical Care AB
112. Urgent Safety Notice for the DFM Transcatheter Aortic Valve System, Direct Flow Medical®
113. Corrective action of Xcelens SA, Switzerland for Cartridge “IDEA cart”
114. Urgent Field Safety Notice for Endo Peanut Auto Suture Blunt Dissector 5mm by Covidien llc
115. Fluoroscopic x-ray system Field extension BV Pulsera
116. Urgent Field Safety Notice for Birmingham Acetabular Cup by Smith & Nephew Orthopaedics…
117. Safety Notice on Ankylos Implant driver C/X with screwdriver, FRIADENT GmbH
118. Field safety corrective action for the Large Oscillating Saw Attachment, Synthes GmbH
119. Urgent Field Safety Notice for Sensis systems by Siemens Healthcare GmbH; Business Area…
120. Urgent Field Safety Notice for LATARJET EXPERIENCE by Medos International SARL
121. Notification of a change to the Instructions for Use for BacT/ALERT®, bioMérieux
122. Lot Recall for FMS Intermediary Tube Sets for Fluid Management, DePuy Mitek
123. Urgent field safety notice for Natal Care ST-LX incubator, Medix I.C.S.A.
124. Urgent Field Safety Notice for ThermoScientificTM OxoidTM CPO30 Cefpirome by Thermo Fisher…
125. Corrective action for ARCHITECT HAVAb-IgM Reagents, Abbott
126. Urgent field safety notice for Natal Care ST-LX incubator, Medix I.C.S.A.
127. GENESIS II Tibial Base Plate
128. Urgent field safety notice for V-PRO 1 / V-PRO 1 Plus / V-PRO maX Low Temperature…
129. Urgent field safety notice for Advantage and Advantage Fit System (Transvaginal Sling) /…
130. Urgent Field Safety Notice for HeartStart FR2/FR2+ by Philips Healthcare, Bothell
131. Urgent Field Safety Notice for Instrument Manager Software by Data Innovations LLC
132. Safety Notice: MR System Blower Box Installation, GE Healthcare
133. Urgent Field Safety Notice for Auriga XL 4007 Laser System + Auriga 30 Laser System by…
134. Safety Notice for Confirma, Inc.´s CADstream®, GE Healthcare
135. Safety Notice for Advantage Workstation: AdvantageSim - Inconsistent DDR, GE Healthcare
136. Safety Notice for Spectra Optia Apheresis System, CaridianBCT
137. Safety Notice for Mobile Monitoring Gateway (MMG), Ascom AB
138. Urgent Field Safety Notice for ARTISET HD S. HC by Gambro Dasco S.p.A.
139. Corrective action for TriniCHECK Control Level 1 and TriniCHEK Control Level 2, Trinity…
140. Safety Notice concerning a problem with eNTEGRA and Xeleris Workstations, GE Healthcare
141. Urgent field safety notice for digital mammography system AMULET (FDR MS-1000) with Biopsy…
142. Lot Recall of the Cervicore Chisel Guide, Stryker
143. Recall for Sterrad 100S Cassette, ASP Advanced Sterilization Products
144. Recall for the E-tegra Stent Graft System, JOTEC GmbH
145. Safety Notice for Olympus Pediatric Resection Electrodes, Olympus Winter & Ibe GmbH
146. Safety Notice for the CDI™ Blood Parameter Monitoring System, Terumo
147. Urgent Field Safety Notice for End Ball by Laboratoire ENDALIS
148. Safety Notice for the OctoNova® Hemofiltration Device, Nikkiso
149. Urgent Field Safety Notice for PATHFAST Myoglobin by LSI Medience Corporation
150. OxiMax N-560 Pulse Oximeter
151. Recall for Terumo Sarns Adult Rigid Intracardiac Suckers, Terumo Europe NV
152. Urgent Field Safety Notice for Rapido; Squod; Forest II; Forest Kids; Express by Vermeiren…
153. Recall for GastroSoft biliary-stents, OptiMed
154. Urgent Field Safety Notice for PATHFAST NT-proBNP by LSI Medience Corporation
155. Information for Xelerate Ceramic 4:1 Cutting Blocks, Stryker
156. Recall for Zenith Branch Endovascular Graft Iliac Bifurcation, Cook
157. Safety Notice for Infinity Acute Care System (IACS) Monitoring Solution, Dräger Medical…
158. Urgent Field Safety Notice for PATHFAST CKMB by LSI Medience Corporation
159. Paxscan
160. Safety Notice for Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50, Philips…
161. Safety Notice for Alaris® Syringe Pumps - all models, CareFusion
162. Corrective action for the BD MAX™ MRSA Assay, Becton Dickinson
163. Recall for the product HQD Flow Probe, Transonic Systems, Inc.
164. Safety Notice for Riata and Riata ST silicone insulated defibrillation leads, St. Jude…
165. Safety Notice concerning Eclipse™ electron Monte Carlo, Varian medical systems
166. Urgent Safety Notice for syngo.plaza, Siemens Healthcare
167. Safety Notice for CS ceiling suspension, Philips
168. Corrective action of syngo Imaging XS, Siemens Healthcare
169. Urgent Field Safety Notice for Posey Connected Twice-as-Tough Cuffs by Posey Products, LLC
170. Safety Notice for hospital beds model AvantGuard, Hill Rom
171. Urgent Safety Notice for counterfeit Nellcor SpO2 Durasensors,
172. Recall of WMEL long necks, MEMOMETAL
173. Recall for the Great Ormond Street GOS Tracheostomy Cannula Set, Teleflex Medical
174. Urgent Field Safety Notice for MobileDiagnost wDR by Philips Medical Systems DMC GmbH
175. Corrective action for optional NIBP units, installed in defibrillators cardioLife, Nihon…
176. Corrective action for m2000sp instrument, Abbott
177. Safety Notice for Femtosecond Laser Systems Models 2, 3 and iFS, AMO
178. Corrective action for the ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET, Tosoh Corporation
179. Safety Notice for syngo Dynamics Version 9.5, Siemens Healthcare
180. Safety Notice regarding syngo Dynamics regional settings for “decimal separator”, Siemens…
181. Information for the Digital Image Capture System SDC HD 0240050888 and 0240050888i…
182. Corrective action on the Eclipse™ 1000 Oxygen Systems, SeQual Technologies
183. Safety Notice for Basic T1 perfusion package, Philips
184. Urgent field safety notice for Enzygnost Borreliosis, Siemens Healthcare Diagnostics…
185. Safety Notice for ARTISTE™ digital linear accelerator, Siemens
186. Corrective Action for Dimension RxL - Reagent Management System (RMS) Power Cord Plug…
187. Urgent Field Safety Notice for T7 Driver AO by Biomet Orthopedics, LLC
188. Urgent Field Safety Notice for Revas Veno-venöse Dual Lumen Kanüle Rheopax by free life…
189. Urgent Field Safety Notice for Arrow OnControl Bone Lesion Biopsy System Tray by Teleflex…
190. Recall of the BIS Bilateral EEG (electroencephalography) Sensors, Covidien
191. Urgent Field Safety Notice to the examination system 3D Optical Coherence Tomography with…
192. Corrective action of Roche for Accu-Chek Inform II, Roche
193. Recall for Oxoid Brain Heart Infusion, Oxoid
194. Urgent field safety notice for ADVIA Centaur XPT, Siemens Healthcare Diagnostics Inc.
195. Safety Notice for Parker 500 Bath - Risk of Electric Shock, ArjoHuntleigh
196. Urgent Field Safety Notice for Artis zee/Q/Q.zen systems by Siemens Healthcare GmbH…
197. Safety Notice for ARTISTE™ MV linear accelerators with syngo® RT Therapist, Siemens
198. Urgent Field Safety Notice for Coagulation Factor V Deficient Plasma by Siemens Healthcare…
199. Corrective action for Architect Cyclosporin, Abbott
200. Safety Information for the Trilux Medical Examination Light L 50, ceiling-mounted version
201. Urgent field safety notice for Quantia Digitoxin, Biokit S.A. / Werfen
202. Urgent field safety notice for Adapter cable ECG-Top Art.-No. AAZ135016-01, Medset…
203. Information for Glucose Biosensors, Siemens
204. Safety Notice for PACS Workstation IDS7 version 12.2.3., SECTRA
205. Urgent field safety notice for the control board in the filter box for MR Imaging System…
206. Recall for MicroCool breathable surgery gowns, Kimberly Clark
207. Urgent field safety notice for Revolution CT tables, GE Healthcare
208. Urgent Field Safety Notice for F-Decalin, F-Octane by Fluoron GmbH
209. Urgent Field Safety Notice for RIDA QUICK ADM Monitoring by R-Biopharm AG
210. Urgent Field Safety Notice for Setpack Sterile surgical jersey / Kitpack w jersey by…
211. Lot recall of Quo-Test A1C Test Kit, EKF-diagnostic GmbH
212. Safety Notice for the Adipose Tissue Treatment Kits 2054-KTA2, Alcis
213. Urgent Field Safety Notice for AQT90 FLEX Analyzer by Radiometer Medical ApS
214. Recall for CA 125II Reagent Lot 144 (ADVIA Centaur Systems), Siemens
215. Safety Information for the PINOFIT® Vertical-Cable-Pull-Machine, PINO GmbH
216. Urgent field safety notice for BF-RhodoLED PDT Device, Biofrontera Pharma GmbH
217. Urgent Field Safety Notice for VITROS Chemistry Products CK Slides by Ortho Clinical…
218. Lot Recall for Renasys Port, Smith & Nephew
219. Urgent Safety Notice for T.E.S.S.® Shoulder System, Biomet
220. Corrective Action for ADVIA Centaur / ADVIA Centaur XP, Siemens
221. Urgent Field Safety Notice for Carestation 620, Carestation 650, Carestation 650c by…
222. Software-upgrade regarding the device NicoletOne Software v5.60.2 through v5.71. with…
223. Recall of ViroCal Duo Software (order number S/VC-DG), Sekisui Virotech GmbH
224. Urgent Field Safety Notice for MaxZero Needleless Connector by Impromediform GmbH
225. Lot Recall for Super Arrow-Flex® Percutaneous Sheath Introducer Set with Integral…
226. Lot Recall of Illumena Luer Syringes, Covidien
227. Recall for Vanguard Lock-on Femoral impactor, Biomet UK
228. Safety Notice for Paradigm Veo insulin pumps, Medtronic
229. Safety Notice for the device cobas c 311 analyzer, Roche Diagnostics GmbH
230. Lot Recall for Gepan® instill, MPC
231. Recall of HIP Stems packaged before February 2008, Wright Medical Technology
232. Safety Notice for AK 200 ULTRA S and AK 200 ULTRA (Incorrect online priming), Gambro
233. Safety Notice for the CyberKnife Systems with the Standard Treatment Couch Patient…
234. Urgent Field Safety Notice for NexGen Offset Stem Extension size 14 and size 17 by Zimmer…
235. Safety Notice for SIMVIEW 3000/NT, Siemens
236. Safety Notice for iPhone-/Android-Applikation „Pfizer Rheumatology Calculator“, Pfizer
237. Safety Notice for Bard® Channel Steerable Sheath, Bard Limited
238. Corrective Action for UniCel DxC Clinical Systems, Beckman Coulter
239. Field Safety Notice concerning the Panda iRes and Giraffe Bedded Warmers
240. Recall of catheters for intracranial pressure monitoring, Spiegelberg
241. Lot Recall for GemStar pump sets, Hospira
242. Safety Notice for the information system Visage 7, Visage Imaging
243. Information for VACS II and VACS III, Dr. Osypka GmbH
244. Recall for CardioVations EndoClamp Aortic Catheter, Edwards Lifesciences
245. Corrective action for Advia Clinical Chemistry Systems Ethanol Reagent, Siemens
246. Field Safety Notice of Leksell GammaPlan and Leksell SurgiPlan
247. Safety Notice for Argus Pro LifeCare, Schiller Medizintechnik GmbH
248. Lot Recall for Provox Vega Voice Prosthesis, ATOS
249. Urgent Field Safety Notice for IMMULITE 2000 HCG by Siemens Healthcare Diagnostics…
250. Safety Notice for ARTISTE with syngo RT Therapist Version 4.1 build 67, Siemens
251. Recall Cystodrain®, COLOPLAST
252. Safety Notice for compact-cart, ITD GmbH
253. Lot Recall for ReNu® Multi-Purpose Solution, Bausch & Lomb
254. Safety Corrective Action regarding the shock lead impedance measurement of COGNIS…
255. Urgent Field Safety Notice for Dimension Vista PROT1CAL & PROT1 CON ( L & M & H) by…
256. Field Safety Notice concerning digital Linear Accelerator Artiste
257. Recall for NexGen Complete Knee Solution-Provisional Articular Surface, Zimmer Inc.
258. Lot recall of Implant Pick-Up EV 5.4 Short, DENTSPLY lmplants Manufacturing GmbH
259. Corrective action for the UniCel DxH 800 Coulter Cellular Analysis System, Beckman Coulter
260. Urgent Field Safety Notice for Quidel Triage Drug Screen Control 1 by Quidel Corporation
261. Safety Notice for Hedrin, Pouxit, Silikom, Etopril and XT Luis, Thornton & Ross
262. Field Safety Notice for syngo Dynamics 6.x, 7.x and 8.x, Siemens
263. Corrective Action for Synchron LX and UniCel DxC Clinical Systems - Operating Software…
264. Recall of the intraocluar lenses PC 430Y Eliteseries
265. Safety Notice concerning Reprocessing Instructions for EndoWrist Instruments, Intuitive…
266. Recall of lot numbers of a OP set from Mölnlycke Health Care
267. Error in German Translation of Combitube Instruction for Use, Covidien
268. Urgent field safety notice for Discovery 3.0T MR750, GE Healthcare
269. Recall of Akreos Advanced Optics Aspheric Intra-Ocular lenses
270. Recall for InterGard Knitted vascular graft, Intervascular S.A.S.
271. Safety Notice for Licox CMP Tissue Oxygen Monitors, Integra LifeSciences
272. Urgent Field Safety Notice for Various Microgenics Application Sheets by Microgenics…
273. Urgent Field Safety Notice for Urisys 1100 by Roche Diagnostics GmbH
274. Safety Notice for Servo Ventilator 300, Maquet
275. Corrective action for the Glucose 201 Analyzer, HemoCue AB
276. Information for ClevAir, MPV TRUMA
277. Lot Recall for Aorfix™ Endovascular Stent Graft, Lombard Medical Ltd.
278. Lot recall of Allevyn Cavity 9 cm x 2.5 cm Tubular Wound Dressings, Smith & Nephew Medical…
279. Recall for MEDAP connection tubes for medical gases, Maquet
280. Safety Notice concerning a corrective action of the defibrillators cardiolife TEC-8300K…
281. Recall for Omnican Pen 31, B. Braun
282. Recall of CADD® Medication Cassette Reservoirs
283. Recall of S4 FW258R K-Wire-Guidung Instrument for Set S4 SC from manufacturer Aesculap AG…
284. Important Notice for XVI Digital imager Software Version: R4.5 and R4.6, Elekta
285. Urgent Field Safety Notice for Alere Afinion ACR Control by Alere Technologies AS (vorher…
286. Recall of ConMed Endoscopic Disposable Polypectomy Snares and Gastrostomy Feeding…
287. Lot recall of UHN - Solid Humeral Nail, SYNTHES
288. Field Safety Notice of Siemens of AXIOM Iconos R200 ND X-ray system
289. Recall for the Trabecular Metal™ Reverse Shoulder Instrumentation Liner Impactor, Zimmer…
290. Urgent Field Safety Notice for HELIOSTAR Balloon Ablation Catheter by Biosense Webster Inc
291. Lot Recall for Amplatzer Sizing Balloon II, AGA Medical Corp.
292. Urgent Field Safety Notice for ORTHOPILOT CAP SINGLE-USE MARKERS by Aesculap AG
293. Urgent Field Safety Notice for Bavarian Guide Wire RU by Medi-Globe GmbH
294. Urgent Field Safety Notice for ddRCombi Trauma, ddRCombi Plus FP by Swissray Medical AG
295. Field safety notice concerning problem with Vatech PaX-Reve3D, Vatech Co., Ltd.
296. Urgent Field Safety Notice for Chromophare by Berchtold GmbH & Co. KG
297. RESONATE CRT-D
298. Specify 5-6-5 Surgical Lead and Specify 2x8 Surg
299. NX software
300. Azurion R1.x
301. Safety Notice for Babylog VN 500, Dräger
302. Urgent Field Safety Notice for Oxoid Ceftriaxone 32 M.I.C.Evaluator strip MA0122 by…
303. Field Safety Notice concerning a potential leak in the Pulmonary Toolkit and Big Bore from…
304. Safety Notice for Philips Precess MRI Patient Monitoring System
305. Urgent Field Safety Notice for Procleix HEV Assay by Grifols Diagnostic Solutions Inc…
306. Field Safety Notice concerning Mammographie X-ray system Diamond
307. Lot Recall for gas filter, mtp Medical Technical Promotion GmbH
308. Recall for Journey partial knee tibial base plates and PE-inserts, Smith & Nephew
309. Recall for Bicarbonate FS, DiaSys Diagnostic Systems
310. Recall of Radiofrequency Cannulae, Stryker
311. Safety Notice for 9100 Series Washer Disinfectors, Getinge
312. Urgent field safety notice for cobas b 123 Sensor Cartridge BG/ISE/GLU/LAC, Roche…
313. Recall for the Microlab STAR Pooling Software Version 3.x, Hamilton Bonaduz
314. Urgent field safety notice for Haemophilus Chocolate agar (HAEM) Ref. 43561, bioMérieux SA
315. Corrective Action for ABL800 and ABL700, Radiometer
316. Information for Gamma3 Trochanteric Nail, Stryker
317. Corrective action for the Advia Centaur Systems Tobramycin Assay, Siemens
318. Urgent Safety Notice for the AES Ankle prosthesis, Transystème
319. Urgent field safety notice for PICC/CVC Securement Device + Tegaderm I.V. Advanced…
320. Recall of Cellabs Pty Ltd. for Pneumo Cel IFA Kit
321. Recall of ADROIT™ 6F Guiding Catheters, Cordis
322. Urgent Safety Notice for the product Monaco, ELEKTA / IMPAC Medical Systems, Inc.
323. Corrective action for the Advia Centaur Systems T4 assay for Advia Centaur, Advia Centaur…
324. Safety Notice for Injectomat TIVA Agilia Syringe Pump, Fresenius Kabi
325. Recall for ImmunoComb II HAV IgM, Orgenics
326. Second Recall for Tryton Side Branch Stent, Tryton Medical
327. Corrective Action for UniMatch Software v4.01, Invitrogen
328. Urgent field safety notice for transducer of DPT-6000 series, CODAN pvb Critical Care GmbH
329. Recall of Quadrox-i Oxygenators
330. Recall for Slidex Staph Kit, Biomerieux
331. Urgent Field Safety Notice for KYPHON Directional Bone Filler by Medtronic Sofamor Danek…
332. Safety Notification concerning a risk for the Injectomat TIVA Agilia syringe pump
333. Recall for specific Intraaortic Balloon Counterpulsation Catheters, Arrow International
334. Urgent Safety Notice for the Digital Accelerator, Elekta
335. Safety Notice for Syngo Imaging PACS, Siemens
336. Safety Notice for BVI CustomEyes Ophthalmic Procedure Kits, Beaver-Visitec International
337. Safety Notice for microTargeting Drive System and Accessories, Medtronic
338. Lot Recall for Optipac Refobacin Bone Cement R, BIOMET
339. Recall for BerliPen 301, Owen Mumford Ltd.
340. Recall for the Plywire Soft Tip - Nitinol guide wire, OptiMed Medizinische Instrumente…
341. Lot-Recall for Epsylar Percutaneous Introducer Sheath, OptiMed
342. Safety Notice for Eclipse Release 6.5 through 10, Varian medical systems
343. Lot-dependent recall of PRISM Reaction Trays, Abbott
344. Field Safety Notice concerning CT Scanner PRESTO and ECLOS from Hitachi Medical
345. Recall for ELEKTRA bimaterial screwed cups, Small Bone Innovations International
346. Information of Mini Bypass Bag of Sorin Group Italia
347. Recall for ABC®Handpieces, ConMed
348. Recall for the Venous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous…
349. Urgent Safety Notice for the Spectra Optia Apheresis System, Terumo BCT, Inc.
350. Urgent Field Safety Notice for Schiller Defibrillationselektrode by Leonhard Lang…
351. Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies
352. Recall for STA Neoplastin R, Diagnostica Stago / Roche Diagnostics
353. Urgent Field Safety Notice for S. Plus by Ganshorn Medizin Electronic GmbH
354. Lot Recall for SynCage-C spine implants, SYNTHES
355. Corrective action for the RHD BeadChip Kit, BioArray Solutions
356. Urgent Field Safety Notice for STA-NeoPTimal 20 with STA-Compact/STA-Compact Max by Stago
357. Information for Omega IV and V tables affecting Advantx-E and Innova systems, GE…
358. Lot Recall for Ethilon, Ethibond, Mersilene and Perma-Hand Silk, Johnson & Johnson
359. Safety Information for M3516A Battery, Philips
360. Urgent Field Safety Notice for Carina by Drägerwerk AG & Co. KGaA
361. Lot Recall for the Shiley Reusable Cannual cuffed Tracheostomy Tubes, Covidien
362. Field Safety Notice concerning inhalation devices Pari Sole N and Pari Sole N Tracheo…
363. Medical Device Alert for all model and lot numbers of the Clampholder for neonates and…
364. Corrective Action/Recall for ABX Micros 60, Horiba ABX SAS / Axonlab
365. Corrective action/Recall for Stratus CS STAT Fluorometric Analyzer, Siemens
366. Safety Information for the implantable left ventricular assist devices Incor, BerlinHeart
367. Lot recall of Target Nano, Stryker
368. Urgent Field Safety Notice for Various Unomedical High Concentration Oxygen Masks by…
369. Recall of the Luxtec UltraLite Pro Headlight, Integra
370. Recall for Foliodress® surgical gowns, Paul Hartmann
371. Urgent field safety notice for EV1000A System, Edwards Lifesciences
372. Lot Recall for SafeSheath Sealing Adapter, CPS SafeSheath Sealing Adapter, GE Healthcare
373. Urgent Field Safety Notice for Sonialvision Series (G4/Safire17/UD150B-40) by Shimadzu…
374. Safety Notice for Carescape Monitor B850, GE Healthcare Finland Oy
375. Safety Notice concerning additional safety precautions for Horizon Cardiology Hemo…
376. Safety Notice for Carescape Monitor B650, GE Healthcare Finland Oy
377. Urgent Field Safety Notice for Access 2 Immunoassay System by Beckman Coulter, Inc.
378. Safety Notice for the Synchrony Respiratory Tracking System, Accuray
379. Urgent Field Safety Notice for HeartMate 3 by Thoratec Corporation
380. Urgent Field Safety Notice for Stone extraction basket (BAS1-Series) by FUJIFILM medwork…
381. Recall for Creatinine (CREA) Flex Reagent Cartridge, Siemens
382. Urgent Field Safety Notice for MyWay by James Leckey Design Ltd.
383. Lot Recall for Model 7060 ACUITY Universal Cutter, Boston Scientific
384. Recall for the Wrap for Medullary Nails, Synthes GmbH
385. Urgent field safety notice for QIAsymphony DSP Kits, QIAGEN GmbH
386. Urgent Field Safety Notice for Philips IntelliVue NMT Patient Cables 98980317458 by…
387. Recall for the product AR ManoShield, Given Imaging
388. Corrective action for the Pioneer® Plus Catheter, Volcano Corporation
389. Urgent Field Safety Notice for Shuntassistant by Christoph Miethke GmbH & Co. KG
390. Safety Notice for the High Energy C Series Clinac®, Varian medical systems
391. Recall for urological and rectal catheters as well as endotracheal suction catheters…
392. Recall concerning DYNAMOMETRIC T handle, Kisco International
393. Recall for the Aqualiner Hydrophilic Guidewires, NIPRO Europe
394. Important Safety Notice for the product Focal/Monaco, Elekta / IMPAC Medical Systems, Inc.
395. Urgent Field Safety Notice for Bridge Occlusion Balloon by Spectranetics Corporation
396. Corrective action for the DRX Evolution Systems w/Premium and Full Featured Wall stands…
397. Lot recall of Metalline products with metal needles, Lohmann & Rauscher GmbH & Co. KG
398. Safety Notice for the product TomoTherapy SharePlan 1.1, RaySearch Laboratories AB
399. Urgent Field Safety Notice for Perikardpunktions-Katheterset. Pleurapunktions-Set by Cook…
400. SOMATOM X.ceed
401. Urgent Field Safety Notice for Willscher Vas Reapproximator Set, Skewers, Reapproximator…
402. Recall for the Coherex WaveCrest® Left Atrial Appendage (LAA) Occlusion System and…
403. Recall for the VFI Pack for Silicone Oil syringes, D.O.R.C. Dutch Ophthalmic Research…
404. Recall of Trigen Intertan Nail, Smith & Nephew
405. Important Safety Notice for the Scherbak weights, Karl Leibinger Medizintechnik GmbH & Co…
406. Safety Notice for Mölnlycke Health Care ProcedurePak®, Mölnlycke Health Care
407. Information for Rotarex® Catheter, Straub Medical
408. Safety Notice concerning about a possible overheating of transformers XVI kV Generator…
409. Safety Notice for disposable pads H315, Nihon Kohden Europe GmbH
410. Safety Notice concerning a problem with Getinge 9100-Series Washer Disinfector, Getinge…
411. Urgent Field Safety Notice for injeTAK Adjustable Tip Needle by Laborie Medical…
412. Safety Notice for Centricity PACS RA 1000 Workstation, GE Healthcare
413. Urgent Field Safety Notice for da Vinci Xi EndoWrist Stapler 45 Reload by Intuitive…
414. Safety Notice for the ACUSON SC2000 ultrasound systems, Siemens Medical Solutions USA…
415. Urgent Field Safety Notice for MR Surgical Suite Option by GE Medical Systems, LLC
416. Safety Notice for the device Power Adapter for Seiko Thermal Printer, ITC
417. Urgent Safety Notice for the Nasopharyngoscope, ESCAD Medical
418. Urgent Field Safety Notice for HIP PRESERVATION SYSTEM SIGNATURE SERIES by ConMed…
419. Corrective action for Acetaminophen, Roche
420. Urgent field safety notice for cobas 6800 / 8800 systems, Roche Diagnostics
421. Recall of CUSA Excel 23 KHz Standard Tip and Flue, Integra LifeSciences
422. Follow-up information for corrective action for PK7300, Beckman Coulter (Olympus)
423. Recall for the AlboGraft Polyester Vascular Graft, LeMaitre Vascular
424. Recall for CELL-DYN Sapphire Hemoglobin Reagent Syringe, Abbott
425. Lot Recall for Pinnacle Cure Sleeves, KERR
426. Safety Notice for Minimally Invasive Technology ™ Offset Rasp Handles-30 Degree Left and…
427. Recall for Complement Control Cells, Immucor
428. Recall for ARCHITECT Reaction Vessels, Abbott
429. Corrective action for the product LIAISON® Biotrin Parvovirus B19 IgM, DiaSorin S.p.A.
430. Recall of sterile surgical drapes and instrument pouches, CareFusion
431. Recall for the Lotus™ Valve System, Boston Scientific International S.A.
432. Urgent field safety notice for AIRVO 2 / myAIRVO 2, Fisher & Paykel Healthcare Limited
433. Recall for "Soft corrugated 22mm breathing Tube", Totax Plastic A/S
434. Recall for Fluido Junior and Fluido Junior Disposable Sets, Sewoon Medical
435. Urgent Safety Notice for the BD EpiCenter™ v6.12A, v6.20A, v6.40A (used in conjunction…
436. Lot recall of mandible distractor (monoaxial) and proximal foot plate, DePuy Synthes
437. BD MAX CT/GC
438. Green Light II Laryngoscope Handle
439. SWISS BI-MANUAL / MONO-MANUAL I/A SYSTEMS
440. Corrective action for the Intuitive Surgical Battery Box contained in the Patient Side…
441. Urgent field safety notice for MOSAIQ, Elekta AB / IMPAC Medical Systems, Inc.
442. Safety Notice for all 3DLINE DMLC systems on an Elekta digital accelerator, Elekta
443. Recall for the EOPA® Arterial Cannula, Medtronic
444. Urgent Field Safety Notice for Accu-Chek Connect Diabetes Management App by Roche…
445. Urgent Field Safety Notice for X-Ray remote controlled table D2RS by Stephanix
446. Recall for the product "Proximal Lighting Insert", Richard Wolf GmbH
447. Urgent Field Safety Notice for Cascadia Interbody System by K2M, Inc.
448. Urgent Field Safety Notice for Corpuls CPR by GS Elektromedizinische Geräte G. Stemple…
449. Lot Recall for Snap-Off Screw, NEWDEAL SAS
450. Safety Notice concerning the use of Tibiaxys® compression guide, Newdeal SAS
451. IntelliVue MX40 Wearable Patient Monitor
452. Safety Notice for the Tibial Impactor - Salto Talaris, Tornier SAS
453. Urgent field safety notice reusable silicon hoses for insufflators and suction /…
454. Recall for STA-Cuvettes, Diagnostica Stago
455. Urgent Field Safety Notice for FTD Vesicular rash by Fast-Track Diagnostics S.a.r.l.
456. Stair-PRO
457. icotec ag: Corrective action for the icotec Pedicle Screw System, CF/PEEK, Polyaxial
458. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
459. Corrective action for the Leica ASP6025 Tissue Processor, Leica Biosystems Nussloch GmbH
460. Recall for the VEPTR® Caudal Rib Supports (Rib-to-Rib Construct only), Synthes GmbH
461. Safety Notice for power wheelchairs with compact lights, Handicare B.V.
462. Recall for the Idylla™ KRAS Mutation Test, Biocartis
463. Urgent Field Safety Notice for Alpha Durasul Einsatz by Zimmer GmbH
464. Recall for Dimension IBCT Flex reagent cartridge, Siemens
465. Problem with Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ linear accelerators, Varian…
466. Corrective action for Oxoid Antimicrobial Susceptibility Testing Disc AMC3 Amoxicillin /…
467. Information for Thermoflect, TechStyles
468. Urgent Field Safety Notice for COBAS PRE-ANALYTICAL SYSTEM (P 512 + P 612) by Roche…
469. Urgent Field Safety Notice for 150CM EXT/INJ LINE STRAIGHT CT/MR by CAIR LGL
470. Recall for the DePuy SIGMA HP FB TIBIAL TRAY IMPACTOR, DePuy
471. Recall of Inferior Border Osteotomy (IBO) Blades, Stryker Instruments
472. Safety Corrective Action regarding Eon Mini model 65-3788 and Brio model 65-6788, St. Jude…
473. Safety Notice for Carescape Monitor B650, GE Healthcare Finland Oy
474. Lot Recall for the Barrier Extremity Drape, Mölnlycke Healthcare AB
475. Corrective action for Hemosil Synthasil APTT Reagent, Instrumentation Laboratory
476. Infinity Acute Care System (IACS) & Patientenmonitor M540 als Einzelgerät by Drägerwerk AG…
477. Safety Notice for Infinity Delta, Delta XL, Vista XL, Gamma XXL and Kappa patient…
478. Corrective action for the Trinica® ALP Instrument Tray, Zimmer Spine
479. Information for Unicondylar Sled Prosthesis, Link
480. Corrective action for Oxoid Antimicrobial Susceptibility Testing Disc MEM10 Meropenem…
481. Urgent Field Safety Notice for DigitalDiagnost by Philips Medical Systems DMC GmbH
482. Urgent Field Safety Notice for Anti-TPO by Orgentec Diagnostika GmbH
483. Urgent Field Safety Notice for Anti-TPO by Orgentec Diagnostika GmbH
484. Corrective action for Berichrom Heparin, Siemens
485. Corrective action for the Access Thyroglobulin Reagent Kit, Beckman Coulter
486. Safety Notice for the surgical lights Sim.LED 5000/7000, S.I.M.E.O.N. Medical GmbH & Co…
487. Recall for therascreen KRAS PCR Kit, QIAGEN
488. Corrective action for the ExacTrac 6.0 Patient Positioning System, Brainlab AG
489. Urgent Field Safety Notice for WiSE CRT Electrode and Delivery Catheter by EBR Systems…
490. Safety Notice for Ultrasonic Surgical Aspiration systems CUSA Excel® and CUSA Excel®+…
491. Urgent Field Safety Notice for Sherpa Active 6F Guide Catheter by Medtronic Ireland
492. Urgent Field Safety Notice for VITEK 2 AST-N248 Test Kit by bioMérieux Inc
493. Recall of Coulter LH 500 Series Analyzer, Coulter HmX Hematology Analyzer, Coulter HmX…
494. Infinity Acute Care System (IACS) & Patientenmonitor M540 als Einzelgerät by Drägerwerk AG…
495. Recall for the Perceval Sutureless Heart Valve, Sorin Group Italia S.r.l.
496. Urgent Field Safety Notice for Randox Total Bile Acids by Randox Laboratories Ltd
497. Safety Notice for the product Accu-Chek Inform II, Roche
498. Urgent field safety notice for MX 16-slice computed tomography x-ray system, Philips…
499. Safety Notice for the Extended Brilliance Workstation - NM, Philips
500. Expanded Recall for ARCHITECT Reaction Vessels, Abbott