International device safety notices

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

1. Further Information for the BrightView XCT Imaging System, Philips Healthcare
2. Tryton Side Branch Stent: The company Tryton Medical has informed about a lot recall of…
3. Urgent Safety Notice for Camino® Intracranial Pressure Monitoring Kits, Integra
4. Recall for the TOPPER® Xtra Absorbent Dressing Pads, Systagenix Wound Management
5. Corrective action for the multiFiltratePRO devices, Fresenius Medical Care
6. Lot recall of Haemolysin Reagent, Thermo Fisher Scientific / Oxoid Limited
7. Urgent Field Safety Notice for Diverse BAREFIBER by Dornier MedTech Europe GmbH
8. Corrective Action for Synchron CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems…
9. Lot recall of gauze compresses MK sterile 10x10 cm 12-fold / 10 x 10 pieces / Box (Art…
10. Safety Notice for UniCel DxC and Synchron LX Clinical Systems, Beckman Coulter
11. Corrective Action of Siemens Healthcare Diagnostics Inc. for Assayed Chemistry Controls 1…
12. Safety Notice for the Carestream DRX-Evolution X-ray system, Carestream Health
13. Urgent Field Safety Notice for Anaesthesia breathing circuits, reusable by Intersurgical…
14. 90d296a8-b02e-cb3c-39ff-90d2dc0088a3
15. Corrective Action for VIDAS TPSA, Biomerieux
16. Safety Information concerning IVD MALDI Biotyper, Bruker Daltonic GmbH
17. Recalls of certain ON-Q-Pumps with Select-A-Flow passive infusion pumps, Flow Corporation
18. Urgent Field Safety Notice for HF-resection electrode, loop, 24 Fr., 12° by Olympus Winter…
19. Safety Information for Respironics V60 ventilators, Philips
20. Corrective Action for CYTO-STAT tetraCHROME reagents, Beckman Coulter
21. Lot Recall of the eccentrical Adaptor Taper of the SMR Shoulder System, Limacorporate
22. Corrective action and recall from Becton Dickinson for BD PrepStain Systems
23. Recall for DiaSys respons 910 analyzer, DiaSys
24. Smiths Medical Int. Ltd. Recalls another lot of the Portex Blue Line Ultra Tracheostomy…
25. Safety Notice for UniCel® DxH™ 800 systems, Beckman Coulter
26. Recall for ProcedurePak products, Mölnlycke Health Care
27. Proximal Femoral Nail (PFN)
28. Urgent Field Safety Notice regarding the 2490C CareLink Monitor software from Medtronic.
29. Safety Information for Puma and Beatle power wheelchairs, Handicare
30. Safety Notice for "Symantec pcAnywhere", Roche Diagnostics
31. Field Safety Notice for EndoWrist instruments used with the da Vinci® Xi™ Surgical System…
32. Recall of polyethylene knee bearings, DePuy
33. Safety Notice for several sets intended to be used with infusion pumps, Unomedical A/S
34. Urgent field safety notice for Volcano s5, s5i, CORE and CORE Mobile systems with software…
35. Urgent Field Safety Notice for SHERIC bipolar cup- Size 56/28 by Amplitude S.A.S.
36. Urgent Field Safety Notice for NovaLine / Tubing Sets for Hemodialysis by Vital Healthcare…
37. Urgent Safety Notice for Contoura 800 series hospital beds, Arjo Huntleigh
38. Urgent Field Safety Notice for Pereyra-Raz Ligature Carrier, Pereyra Ligature Carrier '75…
39. Urgent Field Safety Notice for TruFocus LIO Premiere by Iridex Corporation
40. Urgent Field Safety Notice for Detector Mounting Screws for Nuclear Medicine Systems by GE…
41. Recall for Matrix 2 ™ Detachable Coils, BOSTON SCIENTIFIC
42. Safety Notice for PerOssal, aap Biomaterials
43. Urgent Field Safety Notice for HeartMate 3 by Thoratec Corporation
44. Lot Recall for dialysis tubing connectors, Gambro
45. Recall Allofit IT Alloclassic Shell (60/MM), Zimmer
46. Urgent Field Safety Notice for DLP Vessel Cannula by Medtronic Inc
47. Urgent Field Safety Notice for MUTARS HD Koppelung C-O-M by implantcast GmbH
48. Corrective action for PCs for use with the AU480, AU680, and PK7300 Systems (InoNet…
49. Urgent Field Safety Notice for Denu Tips und Oocyte Aspiration Needles by Gynemed GmbH &…
50. Zimmer: Recall for the product PERSONA The Personalized Knee System Tibial General…
51. Urgent Field Safety Notice for Breathing circuits VentStar Helix by Dräger Medical GmbH…
52. Field Safety Notice about a recall of the joysticks from the Axiom Luminos dRF from…
53. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
54. Recall for Vitros ECi / ECiQ Immunodiagnostic Systems, Ortho
55. Lot Recall of AVAIRA Toric contact lenses, CooperVision
56. Field Safety Notice concerning a required software update for DigitalDiagnost x-ray…
57. Corrective Action for AU Clinical Chemistry Analyzers, Beckman Coulter
58. Recall for the Inflation Device, B. Braun Melsungen AG
59. Recall for the Symed Laryngoscope Handles, preOx.RS GmbH
60. Safety Notice for XPREZZON-Bedside-Monitor, Spacelabs Healthcare
61. Safety Notice for DePuy S-ROM Noiles Distal Femoral Cutting Guide, DePuy Orthopaedics Inc.
62. Safety Notice for the iPlan RT Dose version 4.1 treatment planning software, Brainlab AG
63. Safety Information for all care beds manufactured 2010-2011, FMB Care GmbH
64. Urgent Field Safety Notice for Hugo RAS Arm Cart Assembly by Covidien llc
65. Safety notice for Advantage Workstation, GE Healthcare
66. Safety Information for the TDP® Gou Gong® lamp, T & K GmbH
67. Safety Notice concerning reprocessing of EndoWrist instruments, Intuitive Surgical Inc.
68. Lot recall of Ammonia reagent, Randox Laboratories Ltd.
69. Urgent Field Safety Notice for intelliPATH FLX by Biocare Medical (Pacheco)
70. Notice of Counterfeit LIGACLIP EXTRA LIGATING CLIP CARTRIDGES (Product Code LT 300)…
71. Lot Recall for Intertan Hex Screw, Smith & Nephew
72. Corrective action / Recall of Oxoid Germany
73. Extended Recall of 1 Day Acuvue TruEye™ contact lenses, Johnson & Johnson Vision Care
74. Urgent Field Safety Notice for Celltac G by Nihon Kohden Corp.
75. Urgent Field Safety Notice for SILK VISTA BABY by BALT Extrusion
76. Corrective action / Recall of Oxoid Germany - Thermo Fisher Scientific for PB5008A
77. Corrective Action for G-6-PDH Control, Trinity Biotech
78. Urgent Field Safety Notice for Alere Afinion 2, Afinion 2, Alere Afinion AS100 by Abbott…
79. Corrective action / Recall of Oxoid Germany - Thermo Fisher Scientific
80. Recall for Micrus Endovascular Microcoil System, Micrus Endovascular Corp.
81. Corrective action / Recall of Oxoid Germany - Thermo Fisher Scientific for PB5039A
82. Recall for Vitrax II, Ophthalmic Viscosurgical Devices (Sodium Hyaluronate 3%)", 0,65 ml…
83. Safety Notice for matrix array transducer on the ACUSON SC2000 ultrasound system, Siemens
84. Corrective action for the VERO™/MHI-TM2000 Linear Accelerator System, Mitsubishi Heavy…
85. Information for G2 Hip-System, Orthodynamics
86. Additional Information for the pCO2 Membrane Box (D788) used with ABL700 and ABL800 Series…
87. Corrective action for the product Liaison® Tg, DiaSorin
88. Recall for Morcellator Cutting Tubes, Richard Wolf GmbH
89. Corrective action for the Abutment Retrieval Instrument and Abutment Retrieval Kit, Nobel…
90. Corrective action and recall of Roche for Cobas 6000 Analyzers
91. Urgent field safety notice for da Vinci Xi 5-8 mm Universal Seal (PN 470361) and da Vinci…
92. Safety Notice for the ApexPro Telemetry System, GE Healthcare
93. Safety Notice for the AC 250 ISC Varian Proton Therapy Delivery System, Varian Medical…
94. Corrective action for the nMARQ® Circular Irrigated Catheter, Biosense Webster
95. Urgent Field Safety Notice for PKG, 1688 Camera Control Unit (CCU) by Stryker…
96. Urgent Field Safety Notice for Single Use Rotatable Clip Fixing Device by Olympus Medical…
97. Corrective action for Behring Coagulation System BCS, Siemens
98. Fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution - IFUAddendum2
99. Field safety notice concerning a navigation inaccuracy of the 18117…
100. Corrective Action for Arkray D-Concept D-01, Arkray
101. Urgent Field Safety Notice for Wombat Living by R82 A/S
102. Urgent Field Safety Notice for Belzer UW Cold Storage Solution by Carnamedica S.. z o.o.
103. CooperSurgical humidifier bottle and syringe filter kit for BT37 Mark I, II Benchtop…
104. Recall for Fem-Flex Femoral Arterial Cannulae, Edwards
105. Safety Notice for Allura Xper, Allura Integris, Multi Diagnost Eleva and Omni Diagnost…
106. Urgent Safety Notice for EF-02D Filter for dialysate purification, Nikkiso
107. Corrective action for the KODAK DirectView DR 7500 System, Carestream Health, Inc.
108. Urgent field safety notice for ECHOPULSE medical device for high intensity focused…
109. Urgent Field Safety Notice for packaging issue various devices by Nobel Biocare AB
110. Recall for BD Q-Syte and MPS Acacia with BD Q-Syte, Becton Dickinson
111. Recall for TeCorp implants, Scient´X
112. Recall for Drill handle, Straumann AG
113. Corrective action/Recall for the TFNA Helical-Blade Impactor, Synthes GmbH
114. Information for helium drive system, Arrow
115. Corrective action for VITEK 2, bioMérieux
116. Recall of i-STAT EC4+ and i-STAT 6+ cartridges, Abbott
117. Corrective action for the Tibial Alignment Guide - iAssist Knee System, Zimmer CAS
118. Urgent field safety notice for Commander Delivery System (Models 9610TF23 / 9610TF26 /…
119. Safety Notice for ULTRA SteriSet, Gambro Industries
120. Urgent Field Safety Notice for Zementierter Müller Geradschaft by OHST Medizintechnik AG
121. Corrective action for the Orsiro, Sirulismus Eluting Coronary Stent System, Biotronik AG
122. Urgent Field Safety Notice for 2m Disposable Patient Hose Systems for MEDUMAT Transport /…
123. Corrective action for Elecsys Anti HBs, Roche
124. Urgent Safety Notice for the Mouse Monoclonal Antibody, Cell Marque Corporation
125. Corrective action / Recall of Beckman Coulter for Access Immunoassay Systems Assay…
126. Urgent field safety notice for iGUIDE 2.1 / iGUIDE 2.2, Elekta AB / Medical Intelligence…
127. Quatuorevo
128. Field safety notice for the Lifting Table Diagnostic from Ergo-Tec GmbH
129. Urgent Safety Notice for Lojer 200-Series treatment tables, Lojer OY
130. Corrective Action for Stratus CS Acute Care D-Dimer CalPak Calibrator, Siemens
131. Safety Notice for NAVISTAR RMT Catheters, Biosense Webster
132. Urgent field safety notice for ADVIA Centaur XPT System (SMN 10711433), Siemens Healthcare…
133. Urgent Field Safety Notice for FreeStyle LibreLink App, FreeStyle Libre 3 App by Abbott…
134. Recall for Oral Fluid Positive Control, Oral Fluid Negative Control and Oral Fluid Cutoff…
135. Potential synchronisation error on ACUSON S2000 ultrasound systems with Advanced SieClear…
136. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
137. Field Safety Notice concerning a potential synchronisation error on ACUSON S1000…
138. Recall of the TDx/TDxFLx Gentamicin Assays, Abbott
139. 54e1b711-47ff-e9d2-c9e8-8412bbd9343a
140. Recall of AxSYM Gentamicin Assays from Abbott
141. Recall of Blood Grouping Reagent Anti-Le BioClone 2.0, Ortho-Clinical Diagnostics
142. Urgent Field Safety Notice for MRIdian Linac System by ViewRay Inc.
143. Safety Notice with iSite PACS from Philips Healthcare
144. Urgent Field Safety Notice for AGFA Digital Radiography X-Ray system DX-D 100 by Agfa…
145. Baxter Prismaflex seadmed tarkvaraversiooniga 8.10 - kaltsiumi süstla pumba ootamatu…
146. Veterinary medicines containing Zinc oxide – Withdrawal of marketing authorisation
147. Strep A Rapid Test Device
148. c68fd799-b458-4e4f-7801-49d314527081
149. Vectris SureScan MRI Lead Kit
150. CADD® Medication Cassette Reservoirs (Non Flow-Stop), 50ml and 100ml. Priority 2…
151. DxI 9000 Access Immunoassay Analyzer
152. Medtronic Valleylab electrosurgical generators - LISA 2 FT10, FX8 turvabülletään
153. EASY CLIP, EASY CLIP XPRESS Osteosynthesis Compression Staple
154. SOMATOM Emotion 6 Slice Configuration and 16 Slice Configuration.
155. CHROMagar E.coli O157 + Cefixime/Tellurite
156. OPTIPAC REFOBACIN REVISION 40
157. Randox Total Bile Acids - kalibreerimise ebaõnnestumine või ebatäpsus
158. Microdase Disks 25Disk/VL
159. Dimension Cilnical Chemistry System LIP Flex reagent Cartridge
160. CooperSurgical hapnikuandurid seerianumbriga 526 - inkubaatorite kuvatavad näidud erinevad…
161. PROBE SAMPLE – cobas c. FSN 1, PROBE SAMPLE – cobas c. Attachment 1, PROBE SAMPLE – cobas…
162. 0f846bbb-968f-825f-7bba-8b15e3ffff34
163. CALEX Cap,
164. H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air…
165. ConvaTec Natura Accordion Flange Convex Cut-to Fit wafer - vale toote suurus pakendis
166. Sphenoid Punch
167. Adult SMART Pad
168. MS2 Mobile Stand (used with the MoorLD12 Laser Doppler Imager)
169. Ventralight ST Mesh with Echo PS
170. MagNA Pure 24 System
171. neoBLUE LED Phototherapy System
172. Selution SLR PTCA Balloon Catheter
173. HeartMate II LVAS
174. HQV 84901
175. BD Vacutainer® Push Button Blood Collection Set
176. 4ae4cf96-21df-472c-37f5-ba09d4fc7934
177. Fabian HFO - Updated IFU
178. Senvelgo 15 mg/ml oral solution for cats – Correct use of product in cats with diabetes
179. Olympus CelonProSurge bipolaarsed aplikaatorid - muudatus vastunäidustustes
180. Precision Round, Distal Bend
181. Dimension Vista Hemoglobin A1c (HbA1c) Flex reagent cartridge
182. Argon Medical Devices SuperCore Semi-Automatic Biopsy Instrument - TÄIENDATUD…
183. Urgent Safety Notice for Sorin Heater Cooler Devices, Sorin Group Deutschland GmbH
184. Information for the dental-unit Esthetika E 80, KaVo Dental
185. Safety Notice for Sarns™ Ultrasonic Air Sensor-Cable, Terumo
186. Corrective action for Responder 2000 defibrillator/monitor, Cardiac Science Corp.
187. Urgent Safety Notice for the power cord of the respiration device VECTOR ET, VitalAire…
188. Urgent Safety Notice for the Light Wand Stylet and Light Wand Introduction pack, Vital…
189. Urgent Field Safety Notice for Geratherm UniqueResc+ by Geratherm Medical AG
190. Recall for Incor LVAD, Berlin Heart GmbH
191. Information to Life Scope J BSM-910K from Nihon Kohden Europe GmbH
192. Urgent Field Safety Notice for BD Manifolds with Stopcocks by Sendal S.L.
193. Recall for the Thoracic Vent Procedure Tray, Uresil, LLC
194. Recall of the Cordis Savvy® LONG PTA Dilation Catheter from Cordis GmbH
195. Corrective action for the T-Lok™ Bone Marrow Biopsy products, Argon Medical Devices, Inc.
196. Field Safety Notice of STERRAD® NX™ Sterilizers
197. Corrective action for the Pull Reduction Device for Percutaneous Drill Guide, Synthes GmbH
198. Safety Notice concerning the FreeSpan™ Traverse and FreeSpan Ultra Twin™ Traverse, Liko AB
199. Safety Notice for Blood Purification Equipment Plasauto ∑, Asahi Kasei
200. Urgent Safety Notice for the Mammomat Inspiration with Stereo Biopsy device, Siemens…
201. Safety Notice for the OCS - Heart device, TransMedics
202. Additional safety and warning information concerning InfectoDell for wart treatment…
203. Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG
204. Urgent Field Safety Notice for NanoKnife Single Electrode Probe by AngioDynamics Inc…
205. Corrective Action for Techno TwinStation, Bio-Rad
206. Recall for Dimension Vista CA19-9 Flex reagent cartridges, Siemens
207. Corrective action for the MobileDiagnost wDR 1 und 2, Philips Medical Systems
208. Recalls of the Pressure Infusion Cuff from the manufacturer P.J. Dalhausen & Co. GmbH
209. Corrective action concerning the HeartSine® samaritan® PAD (public access defibrillators)…
210. Corrective action for the Ascenda™ Intrathecal Catheters / Revision Kits, Medtronic
211. Corrective action of Alifax TEST 1 Laboratory ESR Analyzer, SIRE Analytical Systems
212. Recall for Russka Rollator Nexus, Ludwig Bertram GmbH
213. Urgent Field Safety Notice for FluoroType CDiff VER 1.0 by Hain Lifescience GmbH
214. Corrective action for FC 500 Flow Cytometry Systems with CXP Acquisition Software, Beckman…
215. Urgent Field Safety Notice for CompoStop by Fresenius Kabi Deutschland GmbH
216. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
217. Corrective action for Power Supply Assembly Sled of Access and Access 2 Immunoassay…
218. Urgent Field Safety Notice for Intraclude device by Edwards Lifesciences Utah
219. Recall of Avanta® Hand Controller AVA 500 HC, Medrad
220. Recall of blood bag systems named Composelect of manufacturer Fresenius Kabi GmbH
221. Recall of Antimicrobial Susceptibility Test Disc Ticarcillin / Clavulanic Acid (TIM85)…
222. Urgent Field Safety Notice for IH-Com Kit Fullversion and IH-Com Kit For Reader by DiaMed…
223. Urgent Field Safety Notice for Intraluminal Staplers (ILS) by Ethicon Endo-Surgery, LLC.
224. Safety Notice for T-Piece Resuscitation Circuits, GE Healthcare
225. Recall of the surgical suture Dafilon Blue 6/0, B. Braun Surgical
226. Corrective action for the D-Fend/D-Fend+ water traps, GE Healthcare
227. Urgent Field Safety Notice for Gallensekretbeutel 1,5 L by Changzhou Hekang Medical…
228. Recall from lots of the Easy Core and Tru Path Biopsy Devices
229. Recall for Anti-Cw micro, Immucor
230. Recall for Clinical Chemistry Alkaline Phosphatase, Abbott
231. Recall of Surgical Clipper Charger base, Medline Industries Inc.
232. Recall of Clinpro Glycine Prophy Powder with TCP, 3M Deutschland GmbH
233. Urgent Safety Notice for Ziehm Solo X-ray system, Ziehm Imaging
234. Recall for the CloverSnare 4-Loop Vascular Retrieval Snare, Cook Incorporated
235. Urgent field safety notice for Seronorm™ Paediatric, SERO AS
236. Safety Notice for BD Plastipak Luer Slip Syringes, Alcon
237. Urgent Field Safety Notice for TnI-Ultra - Biotin Interference, Siemens Healthcare…
238. Corrective Action of Siemens Healthcare Diagnostics Inc. for IMMULITE
239. Corrective Action of Siemens Healthcare Diagnostics Inc. for calibrators
240. Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare
241. Field Safety Notice concerning a software update of the automated external defibrillators…
242. Urgent Field Safety Notice for Jackson-Pratt Perforated and Hemaduct Wound Drainage System…
243. Corrective Action for CELL-DYN Emerald, Abbott
244. Information for Prevision®-Modular Revision Prosthesis, Aesculap
245. Urgent Field Safety Notice for Sensis, Sensis Vibe Combo, Sensis Vibe Hemo by Siemens…
246. Recall for Dimension Vista System Flex reagent cartridges, Siemens
247. Urgent Field Safety Notice for Idova, Iforia, Ilesto/Inventra, Iperia, Itrevia/Ilivia…
248. Safety Notice for Pathfinder Bone Awl, Abbott Spine
249. Recall for Stryker Navigation PC SPC-1 system, Stryker Navigation - Stryker Leibinger
250. Safety Notice for the Magnus Hybrid operating table, Maquet Getinge Group
251. Urgent Safety Notice for the M-Biopsy™ Coaxial lntroducer Needle, Mermaid Medical A/S
252. Gemstar Pain Management Infusion Pump
253. Urgent Safety Notice for Ingenia 1.5T and Ingenia 3T, Philips
254. Recall of all EIUS Tibial and Femur Implants and of all Titan EIUS Femur Implants, Stryker
255. Safety Notice for the MultiDiagnost Eleva with cable swivel, Philips Healthcare
256. Urgent Safety Notice for the Sonopet Consoles, Stryker Instruments
257. Safety Notice for THERAKOS™ CELLEX™ Photopherese System
258. Urgent Field Safety Notice for Vamp Optima by Edwards Lifesciences LLC
259. Corrective action for the products Nail Insertion Sleeve, elastic T2 Tibia SPI Ø8-11 and…
260. Lot recall of RAPID Hp StAR Kit (K671411-2), Oxoid Limited / Thermo Fisher Scientific
261. Urgent Field Safety Notice for Pump Kit, CADD SOLIS VIP MDL 2120 by Smiths Medical ASD…
262. Recall of the Wallace Oocyte Recovery Needles from Smiths Medical International Limited
263. Safety Notice regarding CONCHATHERM® NEPTUNE™HEATED HUMIDIFIER, Teleflex
264. Urgent field safety notice for ARGENE products, bioMérieux SA
265. Urgent Field Safety Notice for HEMASHIELD GOLD - HEMASHIELD PLATINUM by InterVascular…
266. Safety Notice for the PIC 50, Welch Allyn
267. Urgent Safety Notice for the FreeStyle Libre Flash Glucose Monitoring System, Abbott…
268. Urgent Field Safety Notice for FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 by Smith & Nephew…
269. Recall of ASTROPAD OPT130, Stihler
270. Field Safety Notice from Maquet GmbH & Co. KG on pedals 1009.81 for operating tables
271. Recall of Elefant® Suction-Irrigation Device, Coloplast
272. Urgent Field Safety Notice for VENTICA skin electrode by Icare Finland Oy
273. Corrective action for Calibrator and Controls A and N, Roche
274. Safety Notice for Clinac® C-Series and Novalis Tx, Varian medical systems
275. Information about training devices, Medica Medizintechnik
276. Urgent field safety notice for proteusPLUS and proteusONE, IBA
277. Urgent Field Safety Notice for HM3 Outflow Graft, HM3 LVAS Kit by Thoratec Corporation
278. Recall for the product Dafilon Blue, B. Braun Surgical S.A.
279. Urgent Field Safety Notice for MiniCollect® TUBE 1 ml 9NC 3,8% by Greiner Bio-One GmbH
280. Recall for Advantage®, 2-Button Turbo Handpiece, ConMed Linvatec
281. Corrective action for Precision 500D, Precision Rxi and Precision MPi X-ray imaging…
282. Lot Recall for the product Bead Block, Biocompatibles Ltd.
283. Software update for Intellispace Portal with software version 4.0 and 4.0.1, Philips…
284. Urgent Field Safety Notice for VLP MINI-MOD 2.0MM STRAIGHT PLATE 6 HOLE by Smith & Nephew…
285. Safety Notice for the Intellispace Portal (ISP) Multi-Modality Tumor Tracking application…
286. Corrective action for the Scherbak weights, Gebrüder Martin GmbH & Co. KG
287. Urgent Field Safety Notice for Rusch TracFlex Plus Set, cuffed by Teleflex Medical Athlone
288. Urgent Field Safety Notice for AlboGraft Polyester Vascular Graft by LeMaitre Vascular…
289. Batch Recall concerning Burr Hole Latex Free Probe Cover with Gel, Microtek Medical B.V…
290. Safety Notice for SEPTOCALM, Septodont GmbH
291. Corrective Action /Recall for Liquid Waste Bottle (Access and Access 2 Systems, as well as…
292. Lot Recall of VORTEK® Double Loop Ureteral Stent Open/Open With Connectable Pusher and…
293. Recall of the Tender Flow Pediatric Arterial Cannulae from Terumo Cardiovascular Systems…
294. Recall for FlatFoot bioabsorbable prosthesis, STRYKER
295. Recall for different medical devices, Teleflex Medical
296. Field Corrective Action from R 82 A/S of High-Low X-Frames
297. Safety Notice concerning a corrective action of the infant incubators Dual Incu i, Incu i…
298. Urgent Safety Notice for the Flexor RTPS Guiding Sheath, COOK Medical Europe
299. Information for Delta/Delta XL-Monitors, Dräger
300. Information for Angiomat Illumena Injector, Mallinckrodt
301. Recall of Endopath 5 mm Curved Dissector with Monopolar Cautery, Ethicon Endo-Surgery
302. Recall of the defibrillation electrodes from ConMed Corporation
303. Urgent Field Safety Notice for Artis zee/Q/Q.zen systems by Siemens Healthcare GmbH…
304. Urgent Field Safety Notice for Atemgasbefeuchter by Pacific Medico Co., Ltd
305. Urgent Field Safety Notice for Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300…
306. Urgent field safety notice for TIGR Matrix Surgical Mesh, Novus Scientific AB
307. Urgent Field Safety Notice for 3M Reston Self-Adhering Foam by 3M Health Care
308. Corrective Action/Recall for Bond Polymer Refine Detection DS9800, Leica Biosystems
309. Safety Notice for the RT Chart function of ARIA, Varian medical systems
310. Urgent Field Safety Notice for BILD2 (Bilirubin direct Gen.2) by Roche Diagnostics GmbH
311. Safety Notice for Extended Brilliance Workspace, Philips
312. Recall of Silo Bags for the treatment of gastroschisis, Medicina
313. Safety Notice for the syngo® RT Therapist 4.2, Siemens Healthcare
314. Urgent Safety Notice for the product: MOSAIQ (Version 2.41 and higher), IMPAC Medical…
315. Urgent Field Safety Notice for ADVIA Centaur / Centaur XP / Centaur CP / Centaur XPT…
316. Recall of the BacT/Alert FA Culture Bottles, bioMérieux
317. Updated Safety Information concerning NDI Disposable Reflective Marker Sphere, Northern…
318. cobas c 111
319. Corrective Action for PLAC Test Reagent Kit, diaDexus
320. Safety Notice for AlphaDuoLap insufflator, GIMMI
321. Information for RapidPoint 400 and 405 Systems, Siemens
322. Urgent Safety Notice - Easypump II Recall, B. Braun Melsungen AG
323. Recall Argoguide Hydrophilic Guide Wire, Argon
324. Urgent Field Safety Notice for Elekta Unity by Elekta Ltd
325. Urgent Field Safety Notice for Epix latis Grasper by Applied Medical Resources
326. Urgent Field Safety Notice for MBT Cemented Keel Tibial Base 2 and ATTUNE FB AND RP by…
327. Urgent Field Safety Notice for Activa Clinician Programmer Application by Medtronic Inc
328. Safety Notice for Savanah Raised Toilet Seat Brackets, Homecraft Rolyan
329. Urgent Field Safety Notice for LeMaitre Over-the-Wire Embolectomy Catheter by LeMaitre…
330. Urgent Field Safety Notice for Brennen Skin Graft Mesher by Mölnlycke Health Care AB
331. Urgent Field Safety Notice for BCS XP System by Siemens Healthcare Diagnostics Products…
332. Recall for Imager™ II Angiographic Catheters and Imager™ II Urology Torque Catheters…
333. Urgent Field Safety Notice for Foot and Ankle Inst. (Drill / Tap and Countersink) by…
334. Incorrect Gantry Angle in Focal Plan Review for XiO IMRT Plans, Elekta CMS
335. Urgent Field Safety Notice for Maxi Sky 1000 and V10 ceiling lifts by ArjoHuntleigh AB…
336. Safety Notice for CARESTREAM DRX-1 System Batteries, Carestream Health
337. Safety Information for certain GlideScope GVL® and AVL Reusable Laryngoscope Blades…
338. Recall of Universal and Ultraclean Electrodes, ConMed
339. Urgent Field Safety Notice for PE Patient Tubing Plug 20/BOX by Teleflex Medical USA
340. Recall of the device Philips NM3 Monitor, Respironics Deutschland GmbH
341. Recall of all Duration® packaged product having an expiration date between September 2011…
342. Lot-Recall for Ziraldent Dental Implants, METOXIT
343. Urgent Field Safety Notice for Output Unit by Hitachi, Ltd.
344. Urgent Field Safety Notice for Wolf mit der Wellenlänge 445nm by A.R.C. Laser GmbH
345. Recall for the OptiSplint Endoprosthesis, optimed Medizinische Instrumente GmbH
346. Corrective action for G8 Hemoglobin F&A2 Calibrator and Hemoglobin F and A2 Control, TOSOH…
347. Urgent Field Safety Notice for Chromogranin A RIA by DIAsource ImmunoAssays S.A.
348. Otto Bock Healthcare GmbH recalls Knee Joints model 3R66 with certain serial numbers.
349. Safety Information for the TPLC Woodpecker for rasp curved, Biomet Deutschland
350. Urgent Field Safety Notice for Custom Tubing set by Maquet Cardiopulmonary GmbH
351. Extended Recall for the product ala®octa, alamedics GmbH & Co. KG
352. Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer…
353. Corrective action/Recall for Dimension Vista Gentamicin (GENT) Flex reagent cartridge…
354. Urgent Field Safety Notice for ASSERACHROM VWF:CB by Diagnostica Stago
355. Information for Exafit stems, Zimmer
356. Corrective action for the products LINK 4+, Link 6+, Link 8+, Fresenius Kabi Deutschland…
357. Updated Urgent Safety Notice for the Strattice Reconstructive Tissue Matrix, LifeCell…
358. Information for Innova 2100IQ and 3100/3100IQ systems, GE Healthcare
359. Urgent Field Safety Notice for G-6-PDH Control Deficient and Normal by Randox Laboratories…
360. Safety Notice for Clinacs with C Series version 7.x, Varian
361. Recall / Corrective Action for Uritest 13G Urine reagent Strips, URIT Medical Electronic
362. Information for Innova 2100IQ ,3100/3100IQ and 4100/4100IQ systems, GE Healthcare
363. Recall of V40 Orthinox femoral heads from Stryker Orthopaedics
364. Corrective Action Ceiling Supply Unit klinoPORT, TRUMPF Medizin Systeme GmbH + Co. KG
365. Urgent Field Safety Notice for T34 syringe pump by Caesarea Medical Electronics Ltd.
366. Corrective action for the FlowCoupler Device, Synovis Micro Companies Alliance, Inc.
367. Information to S-ROM-hipshaft from DePuy
368. Urgent Field Safety Notice for Aequalis Humerail Nail Drill Bit Sterile by TORNIER Inc
369. Field safety notice about a problem with the RoboCouch® Patient Positioning System
370. Urgent Safety Notice for the Application Instrument of Sternal ZipFix™, Synthes GmbH
371. Corrective Action for Dimension Vista V-LYTE Fluids, Siemens
372. ossibility of leaking packages of several products of the Tissue Guard product family…
373. Safety Update for e.cam regarding unintended mechanical motion, Siemens Medical Solutions…
374. Recall for TactiCath Catheters, Endosense
375. Corrective action for the Aequalis IM Nail Targeting Jig, Tornier Inc.
376. Urgent field safety notice for Statlock IAB Stabilization Device (Mega / Sensation Plus…
377. Recall of UNI SCORE tibial tray / UNI SCORE femoral component / EXTREME diaphyseal nail /…
378. Information about Macrolane for breast augmentation, Q-Med/Galderma
379. Recall for a surgical kit for femoropopliteal bypass surgery, Mölnlycke Health Care
380. Synthes GmbH: Corrective action for the product Locking Screw Diameter 3.5mm, Length 14mm
381. Urgent Field Safety Notice for Pedicle Access Kit (PAK) Needles by Medtronic Sofamor Danek…
382. Corrective action for the Precision 500D and Advantx Legacy/Legacy-D Radiographic and…
383. Urgent field safety notice for Columbia CNA Aesculin Selective Agar / McConkey Agar No. 3…
384. Field Safety Notice of arterial filter Quart from Maquet Cardiopulmonary AG
385. Safety Notice for Planmeca Delight, Planmeca
386. Urgent Safety Notice for the TruCal Lp (a) 21 calibrator, DiaSys Diagnostic Systems
387. Urgent Field Safety Notice for OAS Pump by Cardiovascular Systems, Inc.
388. Urgent Field Safety Notice for mylife App by SINOVO health solutions GmbH
389. Lot-Recall for SKY fast & fixed abutment 0°, BREDENT MEDICAL
390. Field Safety Notice concerning a corrective action of Mobile Workstation WM-P1 Series…
391. Corrective action for the Enzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance System…
392. Urgent field safety notice for Monaco RTP System, IMPAC Medical Systems Inc. / Elekta AB
393. Abbott Vascular recalls certain lots of the Voyager NC Coronary Dilationcatheter
394. Safety Notice for the ACUSON S1000, ACUSON S2000, or ACUSON S3000 ultrasound systems…
395. Urgent Field Safety Notice for med. stream 3000 by NM Stahlgeräte GmbH
396. Corrective action for the Volcano S5 and Core Family with SW version 3.3/3.4, Volcano…
397. Urgent field safety notice for DBS Extensions, Medtronic
398. Urgent Field Safety Notice for In2Flow Nasal cannula by Hamilton Medical AG
399. Recall for Genesis II Mobile Bearing Inlay, Smith & Nephew
400. Corrective action for the AKITA JET and AKITA² APIXNEB inhalation systems manufactured by…
401. Recall for Embolectomy Catheter, Teleflex Medical
402. Information for VVsky Navigation Plattform, BrainLAB
403. Information for Elecsys Thyroglobulin, Roche Diagnostics
404. Lot Recall for BD 5 ml Plastipak Syringe Luer-Lok-Tip, Becton Dickinson
405. Safety Notice for the product "Neue Ulmer Hüftorthese", Nea Tec
406. Corrective Action for Afinion AS100 Analyzer and Afinion CRP, Axis Shield
407. Recall for Tecnis™ 1-Piece IOL, AMO
408. Urgent Field Safety Notice for Allura Xper and UNIQ by Philips Medical Systems Nederland…
409. Lot Recall for the Cruiser Hydro Coronary and Peripheral Artery Guide Wire, Biotronik
410. Safety Information for the Invacare Dolomite rollators, Invacare Rea AB
411. Recall for the TransWarmer® Infant Transport Mattress, CooperSurgical
412. Urgent field safety notice for Double Balloon Catheter / Isofuse Isolation Aspiration…
413. Urgent Field Safety Notice for UniCel DxH 800/600 Cellular Analysis Systems by Beckman…
414. Urgent field safety notice for IRIDICA, Abbott Molecular Inc.
415. Safety Notice for Access Thyroglobulin Reagent, Beckman Coulter
416. Recall of Frazier Micro suction cannula, pfm medical
417. Safety Information for the ACUSON S2000, S3000 with virtual touch IQ option, Siemens…
418. Recall for Dimension EXL LOCI Cardiac Troponin I, Siemens
419. Lot recall of insertion instrument Primaro Cup and Primaro Cup MIS, OHST Medizintechnik AG
420. Urgent Information about the safe use of a dialysis tube set, B. Braun
421. Corrective action for the AGC Dual Articular 2000 Knee Femoral Component, Biomet UK Ltd.
422. Recall of BD Visitec Nucleus Hydrodissector, Becton Dickinson
423. Field Safety Notice for the Groove powerchair from the company Sunrise Medical
424. Recall for Dimension EXL LOCI Cardiac Troponin I reagent cartridges, Siemens
425. Recall regarding the 23 mm Engager™Transcatheter Aortic Bioprosthesis, Medtronic 3F…
426. Urgent Field Safety Notice for deep brain stimulation devices Activa PC, Activa SC and…
427. Safety Notice for Varian High-Energy Clinac® linear accelerator, Varian medical systems
428. Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG
429. Recall for ProTime PROTIMEINT, ITC
430. Recall for the RT-PLUS™ Modular Femoral Components due to a packaging issue, Smith &…
431. Urgent Field Safety Notice for Vitamin D kit, 25-hydroxyvitamin D3 by IBL International…
432. Safety Notice for syngo ® RT Therapist 4.2, Siemens Healthcare
433. Corrective action for the RHK femoral components, Biomet UK Ltd.
434. Urgent Field Safety Notice for Langston Dual Lumen Pigtail Catheter by Vascular Solutions…
435. Safety Notice for Epicor UltraWand LP Handheld Ablation device, St. Jude Medical
436. Urgent Field Safety Notice for ORTHO Workstation by Ortho Clinical Diagnostics Inc.
437. Urgent Safety Notice for the ACUSON S Family ultrasound systems, Siemens Medical Solutions…
438. Recall from DiaSys for TruCal HbA1c liquid Product codes
439. Corrective action for the AB SCIEX IVD-MS™ Analyzer device, AB SCIEX
440. Recall Battery Packs for LifeVest Wearable Defibrillator, Medicor
441. Urgent Field Safety Notice for 8mm Bone Dowel Harvest Tube by Biomet Inc
442. Recall of femoral heads from Stryker Orthopaedics
443. Corrective action for the product iPlan RT Dose version 4.0 and 4.1, Brainlab AG
444. Urgent Field Safety Notice for Lasertube (Rubber) Laser resistant tracheal tube, cuffed…
445. Safety Notice for the VITROS® 5,1 FS Chemistry System, Ortho-Clinical Diagnostics, Inc.
446. Important Safety Information for Babytherm 8000WB and Babytherm 8004 / 8010 for newborns…
447. Urgent Field Safety Notice for ANKYLOS Tri-Spade Drill GS A8 by Sirona Dental Systems GmbH
448. Urgent Safety Notice for the product RadiForce RX440, RX650, RX850 and GX540, EIZO…
449. Urgent Safety Notice for the ADVIA Chemistry Acetaminophen Reagent, Siemens Healthcare…
450. Information concerning CT-scanners, Philips
451. Corrective action for the Fixation kit N20, Radiometer Basel
452. Urgent Safety Notice for the Hi-Art Treatment System, TomoTherapy Incorporated
453. GE MR Systems
454. GentleCool Pro Cryogen Canister
455. Recall of the Instrument Set for the Lubinus SPII Anatomically Adapted Hip Prosthesis…
456. Revision of directions for use concerning Wingspan® Stent with Gateway® PTA Balloon…
457. Corrective action for VITEK 2 and VITEK 2 Compact, bioMérieux
458. Recall for ABL90 FLEX analyser, Radiometer
459. Corrective action for the Efficia DFM100 Defibrillator/Monitor, Philips Healthcare
460. Urgent field safety notice for Dimension Vista Flex Homocysteine (HCYS) reagent cartridge…
461. Recall Variant II Turbo Hemoglobin System, Bio-Rad
462. Safety Notice for Operation table top 1150.16B0, Maquet
463. Urgent Field Safety Notice for Dornier Thulio Single Use Performance Laserfasern by…
464. Urgent field safety notice for Teosyal Ultimate and Teosyal PureSense Ultimate, TEOXANE…
465. Lot Recall for T.E.S.S. Shoulder Prosthesis Glenoid Reamer, Biomet
466. Lot recall of heart catheter set Oberhavel, hamamed Klinik- und Spezialprodukte GmbH
467. Urgent Field Safety Notice for Univation X Kneesystem by Aesculap AG
468. Spinal Rod Cutter
469. 73a82a38-b2d3-24c2-f5d4-d499425534a8
470. CareLink Programmer; CareLink Encore Programmer
471. ADVIA Centaur Cleaning Solution
472. Easypump C-bloc RA OnDemand (Variante Select-A-Flow)
473. Corrective action for the Reflotron Uric Acid test, Roche Diagnostics GmbH
474. Urgent Safety Notice for BD BBL™ Vancomycin Screen Agar, Becton, Dickinson & Company
475. Field Safety Notice concerning X-ray systems OrbixTop and ArcoSphere
476. Safety Notice for Enteral Nutrition Pump APPLIX Smart/Vision, Fresenius Kabi
477. Urgent field safety notice for various IVD, Erba Lachema s.r.o.
478. Urgent Field Corrective Action for N Latex HCY / N Latex HCY (BCS XP) reagent, Siemens…
479. Follow-Up Information for the product Panbio Q Fever IgM ELISA, Standard Diagnostics, Inc.
480. Urgent Field Safety Notice for AnaConDa by Sedana Medical AB
481. Software update for Intellispace Portal with software version 4.0 and 4.0.1 und Extended…
482. Recall of Gamma Screw Gauge, Stryker
483. Urgent Safety Notice for the Standard Uniflow Co-Axial Breathing System, 2 m…
484. Urgent Field Safety Notice for Heater-Cooler 3T/1T by LivaNova Deutschland GmbH
485. Recall of lnnocor Pulmonary function test device, INNOVISION ApS / Medset Medizintechnik…
486. Recall for the Acumed 1.5 mm & 2.3 mm MultiScrew Depth Gauges, Acumed LLC
487. Urgent Field Safety Notice for MEERA EU with Drive Unit by Maquet GmbH
488. Urgent Field Safety Notice for NF-light ELISA by UmanDiagnostics AB
489. Field Safety Notice about Signa MR systems with TRM gradient subsystems
490. Safety Notice concerning VENTIlogic LS und VENTIlogic plus ventilators, Weinmann
491. Urgent Safety Notice for GL Control N and P on the Innovastar®, DiaSys Diagnostic Systems…
492. Urgent Field Safety Notice for NEXUS / PDMS by NEXUS / DIS GmbH
493. Safety Notice for Kodak DirectView DR 9500, Carestream Health
494. Urgent Field Safety Notice for Soft Denudation Tips + Follikel Punktions Systeme by…
495. Urgent Field Safety Notice for Epix Universal Clip Applier by Applied Medical Resources…
496. Recall UHR Universal Head Bipolar Components, Stryker
497. Safety Notice for Compat Go Pump, Nestlé Healthcare Nutrition
498. Information for TC Plus-, VKS- and RT Plus, Smith & Nephew
499. Update for CeCon 3000 / concentrate lines, DWA
500. Safety Notice and Update for control units MICROSPEED UNI / ARTHRO, Aesculap
501. Recall for KyphX HV-R Bone Cement, Elmdown Ltd.
502. Urgent Safety Notice for the Parechovirus r-gene® product, bioMérieux SA
503. Urgent Field Safety Notice for Logiq by GE Medical Systems Ultrasound and Primary Care…
504. Recal of the Vortek™ ureteral stents from Coloplast A/S
505. Lot Recall: Cephalomedullary Lag Screw Inserter for Zimmer ® Natural Nail™ System, Zimmer
506. Recall for the HD Autoclavable Camera Head, Olympus
507. Corrective action for the Sysmex CS-2000i/CS-2100i/CS-5100 System, Siemens Healthcare…
508. Lot Recall for Calistar A and Calistar P, Promedon S.A.
509. Urgent Field Safety Notice for Universal sets BARRIER + Orthopaedic BARRIER by Mölnlycke…
510. Urgent Field Safety Notice for ClearCanvas RIS/PACS by Synaptive Medical Inc
511. Information for STERRAD Sterilizer, Ethicon
512. Corrective action of the Sesamoid Plasty Workstation, Zimmer
513. Corrective action for Mueller Hinton 2 Agar, bioMérieux