International device safety notices

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

1. Lot recall of Betafine Universal Pen Needles 30G-8 mm, Promisemed Hangzhou Meditech Co…
2. Urgent field safety notice for UniCel DxH 600 / 800 Cellular Analysis System, Beckman…
3. Urgent Field Safety Notice for BD MAX Vaginal Panel & UVE Specimen Collection kit by…
4. Corrective action for BacT/Alert PF PLUS and FA Plus Culture Bottles, bioMérieux
5. Urgent Field Safety Notice for ARCHITECT BNP Calibrator kit and ARCHITECT BNP Control kit…
6. Safety Notice concerning a corrective action of the Philips Invivo Expression MRI Patient…
7. Urgent Field Safety Notice for SureForm45/60, Cannula Seal, Arm Drape, Obturator by…
8. Urgent Field Safety Notice for ARTIS pheno systems with software version VE10A by Siemens…
9. Recall for the products DERESON® (GIRO) AF, ENDES AF, ULTRADESMIT® AF and BOHRTAN® AF…
10. AT-102 / AT-102 plus / AT-10 plus / AT-104 PC / AT-104 PC ErgoSpiro / MS-2007 / MS-2010 /…
11. Recall for the Access Immunoassay Systems and Access hLH Calibrators, Beckman Coulter
12. Urgent Field Safety Notice for 980 Ventilator, Compressor Configuration, Germany (PB 980)…
13. Recall of one batch of the product AT LISA 809MP, Carl Zeiss Meditec AG
14. Lot recall of OSSEOTITE Certain Implant 4 x 11.5 mm (IOSS411), Zimmer Biomet / Biomet 3i
15. Recall for Medex Intracranial Drainage Sets, Smiths Medical Deutschland GmbH
16. Urgent Field Safety Notice for VITROS Na+ Slides by Ortho-Clinical Diagnostics, Inc.
17. Urgent Field Safety Notice for Trinity Acetabular Shell by Corin Medical Ltd.
18. Safety Notice for the CoreValve™ AccuTrak™ Delivery Catheter System, Medtronic
19. Second Safety Notice for the Cadisc™-C Endplate Handles and Blades, Ranier Technology…
20. Urgent Field Safety Notice for Hydroline Trumpet Valve by Cardinal Health
21. Urgent Field Safety Notice for Alinity i BNP Calibrators and Alinity i BNP Controls by…
22. Lot Recall of the ATR 120 Autotransfusion Reservoir, Fresenius Kabi
23. Urgent Field Safety Notice for Sheridan ET Tubes by Teleflex Medical USA
24. Urgent Field Safety Notice for Enzygnost Anti-VZV/IgG - lower absorbance values, Siemens…
25. Urgent Field Safety Notice for CardioMems Hospital and Patient Electronic System by S…
26. Corrective action for the product RealAccurate Respiratory RT PCR Kit v2.0, PathoFinder…
27. URGENT MEDICAL DEVICE CORRECTION for ARIA® for Radiation Oncology, ARIA® Oncology…
28. Urgent Field Safety Notice for Medical Face Mask by Sword Xiantao Disposable Protective…
29. Recall for the products megro ID plus und megroCID, Megro GmbH & Co. KG
30. Urgent Field Safety Notice for Rheumatoid Factors 2, Rheumatoid Factors Control by Thermo…
31. Recall for the product "Setzkopf Primaro-Pfanne", OHST Medizintechnik AG
32. URGENT FIELD SAFETY NOTICE for Harmonic ACE+7 codes HARH23, HARH36, HARH45, Ethicon…
33. Corrective action for Dxl 600 and Access 2, Beckman Coulter
34. Recall for the product GAMMEX® PF, Ansell N.P Sdn. Bhd.
35. Urgent Field Safety Notice for Contour next Blutzuckerteststreifen 25 S.ück by Ascensia…
36. Software Upgrade for DigitalDiagnost X-ray systems with 3.0.x Software, Philips Medical…
37. Recall of specific lots of the Large Needle Driver and Mega Needle Driver EndoWrist®…
38. Recall for the Firebird Spinal Fixation System Modular Screwdriver, Orthofix
39. Urgent Field Safety Notice for Silicone Implant and Expanders by Groupe Sebbin SAS
40. Safety Notice for overhead Video Monitor Suspension of Precision 500D, Legacy, Prestilix…
41. IMPORTANT SAFETY INFORMATION for Soluscope Serie 4 PA, Soluscope SAS
42. Urgent Field Safety Notice for CentraLink(R) Data Management System and Atellica(R) Data…
43. Urgent Field Safety Notice for Dilatation balloon (DIL1-A1-Series) by FUJIFILM medwork…
44. Lot recall of NIO-A, WaisMed Ltd.
45. Urgent Field Safety Notice for Arctic Sun Temperature Management System by Medivance, Inc.
46. Urgent Field Safety Notice for Silicone Implant and Expanders by Groupe Sebbin SAS
47. Corrective action for the product Relief ACP Oral Care Gel, Discus Dental, LLC
48. Urgent Field Safety Notice for Halo skull pins by Össur hf.
49. Urgent Field Safety Notice for Silicone gel-filled sizers by Groupe Sebbin SAS
50. Corrective action for the UniCel DxH 800 and 600 Coulter Cellular Analysis System, Beckman…
51. Lot recall of QMS Everolimus Immunoassay, Thermo Fisher Scientific / Microgenics…
52. Urgent field safety notice for Stop Solution (EL0105) and ELISA kits, Focus Diagnostics
53. Urgent Field Safety Notice for Alinity i Homocysteine Reagent Kit by Abbott GmbH
54. Recall for the TWISTER™ PLUS Rotatable Retrieval Device, Boston Scientific (Distributor) /…
55. Urgent Field Safety Notice for Shiley Adult Flexible Tracheostomy Tube with TaperGuard…
56. Urgent Field Safety Notice for TECOTHERM NEO by TEC COM GmbH
57. URGENT FIELD SAFETY NOTICE for T-Piece Circuit, Mercury Medical
58. Urgent Safety Notice for the Trophy IRIX scissor arm of the Trophy IRIX Intra-oral X-Ray…
59. Urgent Field Safety Notice for Centricity PACS IW by GE HEALTHCARE INTEGRATED IT SOLUTIONS…
60. Urgent Field Safety Notice for Endo GIA Surgical Stapling Single Use Loading Units…
61. Corrective action for IMMULITE Calcitonin Control Module, Siemens Healthcare Diagnostics
62. Urgent field safety notice for iGUIDE / HexaPOD, Elekta AB / Medical Intelligence…
63. Urgent Field Safety Notice for Quava by Vermeiren N.V.
64. Urgent Field Safety Notice for pH = 7.0 buffer solution for S. automated systems by RAL…
65. Lot-recall IMPRINT II REGULAR BODY VPS, 3M Deutschland GmbH (formerly known as ESPE)
66. Urgent Field Safety Notice for HUMAN ASSAYED MULTI-SERA Level 2 by Randox Laboratories Ltd
67. Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope…
68. Urgent Field Safety Notice for Getinge WD15 Claro by Getinge Disinfection AB
69. Stryker Neurovascular: Recall for Excelsior Microcatheters, GDC Coils, Neuroform EZ Stents…
70. Urgent Field Safety Notice for Patientenlifter Carlo by Beka Hospitec GmbH
71. Chariot Guiding Sheath
72. mylife Pura test strip
73. c967e507-9530-52a5-e5ba-871149f66ea0
74. Safety Notice for Centricity PACS-IW versions 3.5.0 through 3.7.3.9 SP2, 3.7.3 SPA10 and…
75. Urgent Field Safety Notice for cobas 8000 core unit by Hitachi High-Technologies…
76. Urgent Field Safety Notice for Kimal Procedure Packs by Kimal Plc
77. Safety Notice for the Leica M525 F50 / Leica M525 C50 Surgical Microscope with XY-Unit…
78. Urgent Field Safety Notice for Percuvance Gripper Grasper Tool Tip by Teleflex Medical USA
79. Corrective action for the product MR Surgical Suite Option, GE Healthcare
80. Urgent Field Safety Notice for Nit-Occlud Implantation Sheath by pfm medical mepro gmbh
81. Safety Notice concerning DRX-Evolution and KODAK DirectView X-ray systems, Carestream…
82. Urgent Safety Notice for the Drill set long, drill stop compatible for D 4.8mm Implant…
83. Urgent Safety Notice for the Centricity PACS-IW with Universal Viewer and Centricity…
84. Urgent Field Safety Notice for IV Sets/ Accessories by Henry Schein Inc.
85. Safety Notice concerning Brilliance CT Big Bore having TumorLOC in versions prior 3.6…
86. Urgent Field Safety Notice for Biopsieprodukte by ADRIA S.R.L.
87. Urgent Field Safety Notice for Biopsieprodukte by M.D.L. MEDICAL DEVICE LABORATORY SRL
88. Urgent Field Safety Notice for MEDICAL DEVICES FOR GYNECOLOGICAL PROCEDURES by RI.MOS SRL
89. Urgent Field Safety Notice for Biopsieprodukte by VIGEO SRL
90. Urgent Field Safety Notice for Injizierbare Hyaluronprodukte (für Gelenke) by Anika…
91. Urgent Field Safety Notice for CK-MB, opt. DGKC / IFCC; GLDH, DGKC by Dialab Ges.m.b.H.
92. Urgent field safety notice for Simplexa HSV 1 & 2 Direct / Flu A/B & RSV Direct / Group A…
93. Urgent Safety Notice for the Accu-Chek Connect Diabetes Management App, Roche Diagnostics
94. Urgent Field Safety Notice for Infant Child Reduced Energy Electrodes by Stryker Medical
95. Urgent Field Safety Notice for BD FACS Universal Loader by Becton, Dickinson and Company…
96. Urgent Field Safety Notice for NeuMoDx Saliva Collection Kit by NeuMoDx Molecular, a…
97. URGENT: FIELD SAFETY NOTICE LifeCycle for Prenatal Screening software Version v4.0 Rev4k…
98. Corrective action for Immulite 2000 and Immulite 2000 XPi, Siemens
99. Urgent Field Safety Notice for SILK intracranial stents by BALT Extrusion
100. Corrective action for AQURE V1.5.4, Radiometer
101. Urgent Field Safety Notice for FLEX. GREIFZANGE bzw. FLEX. PE-ZANGE by Richard Wolf GmbH
102. Urgent field safety notice for Anaplasma phagocytophilum IFA IgM Kit (IF1450M), Focus…
103. Urgent Field Safety Notice for Mobile Phase A by Chromsystems Instruments & Chemicals GmbH
104. Urgent Field Safety Notice for IMMULITE 2000, IMMULITE 2000XPi by Siemens Healthcare…
105. Safety Notice for sterEOS workstation, EOS imaging
106. Urgent Safety Notice for the Puritan Bennett™ 980 Series Ventilator System, Covidien
107. Further updated Information for the LH 750 and LH 780 Hematology Systems, Beckman Coulter
108. Urgent Safety Information for the AQURE FLEXLINK, Radiometer
109. Urgent Field Safety Notice for SAFIL & NOVOSYN by B. Braun Surgical S.A.
110. FIELD SAFETY NOTICE - Brainlab Radiation Treatment Planning Software, Brainlab AG
111. Safety Notice for Targon FN plate and the Telescrews, AESCULAP
112. Urgent Field Safety Notice for Vscan Extend by GE Vingmed Ultrasound A/S
113. Urgent Field Safety Notice for cobas c 501 module / cobas c 502 module by Hitachi…
114. Corrective action for Dimension® TACR Flex® Reagent Cartridges, Siemens
115. Urgent Field Safety Notice for Arthroline Stanze B 4,6MM H1,6MM by Richard Wolf GmbH
116. URGENT FIELD SAFETY NOTICE for PowerStar Bipolar Cable, ETHICON
117. Urgent Field Safety Notice for Centricity Universal Viewer by GE HEALTHCARE INTEGRATED IT…
118. Urgent Field Safety Notice for Vanguard Knee PS Tibial Bearing by Biomet Orthopaedic LLC
119. Urgent Field Safety Notice for Senographe Pristina and Pristina Serena by GE Medical…
120. Urgent Field Safety Notice for Dynavox T10 and Dynavox T15 by Tobii AB
121. Lot recall of Dryline II, Shenzhen Mindray Bio-Medical Electronics Co. Ltd.
122. Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA
123. Urgent Field Safety Notice for Aptio Automation by Inpeco SA
124. Lot recall of Vanguard 360 Revision Knee System - Tibial Augment Bolts, Zimmer Biomet
125. Corrective action for the diode laser devices Medilas D12 (Medilas D Opal), Dornier…
126. Lot recall of Oxoid™ ThermoScientific™ GC Agar / CM0367, Thermo Fisher Scientific
127. Urgent Field Safety Notice for SERVOX Silberkanüle (alle Modelle, Größen und Varianten) by…
128. Software Upgrade required on DigitalDiagnost X-ray systems with software versions 2.0.2…
129. Urgent Field Safety Notice for Urinary Metanephrines by HPLC, Bio-Rad Laboratories GmbH
130. Urgent Field Safety Notice for Amulet S. Amulet F/ Innovality by FUJIFILM Corporation
131. Urgent field safety notice for ProCarve Knee Joint and Foot, Otto Bock HealthCare GmbH
132. Urgent Field Safety Notice for Philips ECG Out Sync Cable by Philips Healthcare
133. Safety Notice for the CLINITEK Status, CLINITEK Status+, CLINITEK Status Connect System…
134. Important Safety Notice for the product MOSAIQ, Elekta
135. Urgent Field Safety Notice for QStat® Cartridges by HemoSonics, LLC
136. Urgent Field Safety Notice for Accu-Chek Insight by Roche Diabetes Care GmbH
137. Safety Advice - use of THUNDERBEAT forceps, Olympus
138. Urgent Field Safety Notice for PLATINIUM by SORIN Group Italia S.r.l. - CRM facility
139. Urgent Field Safety Notice for balanSys RP Tibial Plateaus TiNbN cem. by Mathys AG…
140. Urgent Safety Information for the TITAN operating table, TRUMPF Medizin Systeme GmbH + Co…
141. Urgent Field Safety Notice for Testicular Implant (Kiwee®) and Vaginal Stent by Coloplast…
142. Modular Stem cylindrical, press-fit cementless
143. Field Safety Notice concerning potentially falsely placed electronic left/right markers on…
144. Recall for IMMULITE®/IMMULITE® 1000 Turbo Troponin I assay, Siemens
145. Olympus Medical Systems Corporation Thunderbeat Type – S - uuendus, tagasikutsumine…
146. XiO Treatment Planning Software
147. Corrective action for Data-Cyte Plus 0,8 %, Medion Grifols Diagnostics AG
148. Safety Notice for Ysio Max, Luminos dRF Max and Luminos Agile Max with software version…
149. Lot recall of Comfort Shield® Barrier Cream Cloths, SAGE PRODUCTS LLC
150. Urgent field safety notice for Heater Unit HU 35 and Heater-Cooler Unit HCU 20 / 30 / 40…
151. Corrective action for the MiniMed Silhouette™ and Sure-T™ infusion sets, Medtronic
152. Urgent field safety notice for SERVO-air, Maquet Critical Care AB
153. Urgent Field Safety Notice for Affinis CoCr head 43/15/2 by Mathys AG Bettlach
154. Refitting of wheelchairs LifeStand LSCO, Permobil
155. Lot recall for Straight Ventricular Catheter F8, 25 cm / Integral Lumbar Drainage-Set /…
156. Urgent Field Safety Notice for Sara Plus by ArjoHuntleigh AB Malmö
157. Lot recall of Trident Universal Impactor / Positioner, Stryker Orthopaedics
158. Urgent Field Safety Notice for QIAsymphony Filter Tips, 1500µl (1024) by QIAGEN GmbH
159. URGENT FIELD SAFETY NOTICE for ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes, Ortho…
160. Urgent Field Safety Notice for Abre Venous Self-expanding Stent System by Medtronic Inc
161. Urgent Field Safety Notice for VITROS 3600, 5600 and XT7600 Systems by Ortho-Clinical…
162. Corrective action for Leica ASP6025, Leica Biosystems
163. Urgent Field Safety Notice for HomeChoice Pro; Homechoice Claria APD Cycler by Baxter…
164. Urgent Field Safety Notice for Swiss LaserClast SmartFibers by Electro Medical Systems…
165. Urgent Field Safety Notice for Sensation Plus 7.5Fr 40cc by Datascope Corporation
166. Product Batch Recall for 3M™ ESPE™ RelyX™ Temp E NP (Cement, Dental, Zinc-Oxide Eugenol)…
167. Field Safety Notice concerning a corrective action of Corpuls 3 defibrillators to which…
168. Urgent Field Safety Notice for Cervios chronOS wedge-shaped by Oberdorf Synthes…
169. Lot Recall for Perthese & Perthese Esthea Breast Implants, Perouse Plastie
170. GE Healthcare nuclear medicine preventive maintenance procedure and schedule update notice…
171. MR Max MRI System
172. Informe de seguridad sobre: SISTEMA DE TOMOGRAFÍA COMPUTARIZADA POR RAYOS X (CT) DE…
173. Recall for the Persona Stemmed 5 Degree Cemented Tibia, various sizes, Zimmer
174. Urgent Field Safety Notice for Infant Warmer Pivot Securing Nut, Fisher & Paykel…
175. Safety Notice concerning the Puritan Bennett™ 840 ventilator, Covidien
176. Urgent Field Safety Notice for Bond Polymer Refine Detection DS9800 by Leica Biosystems…
177. Urgent Field Safety Notice for Fabian HFO / HFOi by Acutronic Medical Systems AG
178. Urgent Safety Notice for the MiSeqDx™ System, Illumina, Inc.
179. Urgent Field Safety Notice for EPi-Sense Coagulation System with Visitrax by AtriCure…
180. Urgent field safety notice for RAPIDPoint 400 / 405 / 500 and RAPIDLab 1200 systems…
181. URGENT FIELD SAFETY NOTICE - REMOVAL for Twist Drill 25x95 mm Cannulated 1,2 mm Thread 30…
182. Urgent Field Safety Notice for TruSystem 3000 by TRUMPF Medizin Systeme GmbH + Co. KG
183. Urgent Field Safety Notice for Offset Head CrCo 50x20;Centered Head CrCo 50x19 by FX…
184. Urgent Field Safety Notice for FS 2-21, FS 2-25 und FS 3-45 by Möller-Wedel GmbH & Co. KG
185. Urgent Field Safety Notice for Zenith Alpha Abdominal Endovascular Graft - ZIMB ZLC ZLBE…
186. Lot recall of Edwards Commander Delivery System Models 9610TF23 / 9610TF26 / 9610TF29…
187. Urgent Field Safety Notice for C-10 Probetester by ES-Medical AB
188. Recall of Codman Disposable Towel Clamp and / or Symmetry Surgical Disposable Towel Clamp…
189. Lot recall of Concept HeatWave Electrode CS-023, ConMed Corporation
190. Urgent Field Safety Notice for Anti C4d by Biomedica Medizinprodukte GmbH & Co KG
191. Urgent Field Safety Notice for DESCOSEPT SENSITIVE WIPES by Dr.Schumacher Gmbh
192. Urgent Field Safety Notice for Advance Enforcer 35 Focal Force PTA Balloon Catheter by…
193. Recall for the Compensator Slider Lambda 6x20, Carl Zeiss
194. Urgent Field Safety Notice for BeneFusion VP1, BeneFusion VP3 by Shenzhen Shenke Medical…
195. Urgent Field Safety Notice for Bellavita NOVA by Drive Medical GmbH & Co. KG
196. Urgent Field Safety Notice for FlexCardio Patient Monitoring System by Invivo Corporation…
197. Safety Notice concerning the Metran High Frequency Oscillation Ventilator model…
198. Urgent Field Safety Notice for Phaseal Secondary Set, C61 by Becton Dickinson & Company
199. Urgent Field Safety Notice for SLIM Handle by Pega Medical, Inc.
200. Philips Xper Flex Cardio patsiendi jälgimissüsteemid - reaalaja EKG ja rõhukõvera…
201. Urgent Field Safety Notice for EQUISTREAM, EQUISTREAM XK, and GLIDEPATH by Bard Access…
202. Urgent Field Safety Notice for ipsogen BCR-ABL1 Mbcr IS-MMR Kit (24),DX Kit, RGQ RT-PCR…
203. Safety Notice concerning Eclipse™ Treatment Planning System, ARIA® Radiation Oncology…
204. Urgent Safety Notice for the MoPyc Stem PTR-S7, Tornier SAS
205. Urgent field safety notice for IMMULITE / 1000 / 2000 / 2000 XPi, Siemens Healthcare…
206. Urgent Field Safety Notice for CORAIL COXA VARA HIGH OFFSET STEM by DePuy France SA
207. Corrective action for Vacuette 2 ml Glucomedics Tubes, Greiner Bio-One
208. Urgent Field Safety Notice for Trial Spacer by TEQUIR S.L.
209. Urgent Field Safety Notice for Custom Procedure Trays by SENGEWALD Klinikprodukte GmbH
210. Urgent Field Safety Notice for Angel cPRP Processing Set (EU) by Arthrex INC
211. Urgent Safety Notice for the Hemolung Cartridge Kit, ALung Technologies
212. Urgent field safety notice for overhead lift Altair / Roomer S, Human Care HC AB
213. Recall of specific lots of the Müller II Cup, OHST Medizintechnik AG
214. Urgent Field Safety Notice for ETHIBOND EXCEL Polyester Suture by Ethicon, Inc.
215. Urgent Field Safety Notice for Disposable Biopsy Needle Kit by Elekta Solutions AB
216. Urgent field safety notice for S5 / C5 Perfusion System, LivaNova / Sorin Group…
217. Urgent Field Safety Notice for ProBP 3400 and GS 777 Wall Transformer by Welch Allyn Inc
218. Urgent Field Safety Notice for ZOLL Pro-padz Radiolucent Electrode by ZOLL Medical…
219. Urgent Field Safety Notice for Ankle Arthrodesis Nail / Proximal Humeral Nail by Stryker…
220. Urgent Field Safety Notice for EndoBarrier Gastrointestinal Liner System, GI Dynamics
221. Urgent Field Safety Notice for FlexCardio Patient Monitoring System by Invivo Corporation…
222. Urgent Field Safety Notice for TactiCathTM Quartz Contact Force Ablation Catheter by…
223. Urgent Field Safety Notice for Centricity Universal Viewer with CPACS Foundations by GE…
224. Corrective action of several batches of LEGION COCR Constrained Femoral device, Smith &…
225. Lot recall of RUSCH - TracheoFlex Tracheostomie Tubes, Teleflex Medical
226. Urgent Field Safety Notice for EliA RF IgM Well by Phadia AB
227. EnTrust
228. Safety Notice for the Aeon Broaches - 38mm offset, Sheffield Medical Products Ltd.
229. Recall of one batch of the Biolox Delta Trinity Modular Heads 36 mm, Corin
230. Corrective Action for the EXPERTlase and MASTERlase diode lasers, KaVo Dental GmbH
231. Safety Notice / Recall for HOYA iSert IOLs, HOYA Surgical Optics GmbH
232. Corrective action for the enteral feeding pump Amika, Fresenius Kabi
233. MEDICAL DEVICE FIELD SAFETY NOTIFICATION for chronOS Inject Bone Void Filler, Synthes GmbH
234. Field Safety Notice for A/V Set DEHP-free PVC for Dialog and /or Single-Needle Adapter, B…
235. Safety Notice for mobile X-Ray systems (Optima XR220amx, Optima XR200amx with Digital…
236. Urgent Field Safety Notice for Jarvik 2000 Heart JHI-001 by Jarvik Heart Inc.
237. SynchroMed™ II
238. Vscan Extend
239. Safety Notice concerning the 550 TxT™ Treatment Table type PRIMUS™, ONCOR™ and ARTISTE™…
240. URGENT DEVICE RECALL NOTICE for Provide Protection Caps and Provide Impression Copings…
241. Urgent Field Safety Notice for QMS Teicoplanin Calibrator by Microgenics Corporation
242. Urgent Field Safety Notice for Discovery MR750w by GE Medical Systems, LLC
243. Urgent Field Safety Notice for Optical Fiber by Quanta System S.p.a.
244. Urgent Safety Notice for the HemoCue® Glucose 201 Microcuvettes, Radiometer GmbH
245. Batch recall of TANDEM Bipolar Hip System, Smith & Nephew Inc.
246. URGENT Field Safety Notice for RIO Base Array, Stryker
247. Urgent Field Safety Notice for Various Stryker Hip products by Howmedica Osteonics…
248. Urgent Field Safety Notice for MAIOREGEN by FINCERAMICA
249. Urgent Safety Notice for the Zimmer® NexGen Trabecular Metal Tibial (Replacement) Impactor…
250. Additional Information concerning the corrective action for AMH Gen II Elisa, Beckman…
251. Urgent Field Safety Notice for Solution (Kit) by REPROLIFE
252. URGENT FIELD SAFETY NOTICE for VariSource™ iX Control Software, Varian
253. Urgent Safety Notice concerning cCrea QC results on ABL 800 analyzers, Radiometer
254. Urgent Field Safety Notice for BHR Cannulated Drill by Smith & Nephew Orthopedics Ltd…
255. CLEO Ti Wheelchair
256. Urgent Field Safety Notice for peelable cannula, microflash 2 Fr by VYGON GmbH & Co. KG
257. Urgent Field Safety Notice for 2019-nCoV Ag Saliva Rapid Test Card by Guangzhou Decheng…
258. Recall of Alcon INFINITI® Ultrasound Fluidik Management Systems (FMS) Single Use PAKs…
259. Urgent Field Safety Notice for MyPTM App by Medtronic Inc
260. Safety Notice for the syngo Imaging XS, Siemens Healthcare
261. Urgent Field Safety Notice for AdVance XP Needle Passers AdVance XP ProcedurePack by…
262. Corrective action for Campylobacter CCDA selective medium, Thermo Fisher
263. Urgent Safety Notice for the Philips Brilliance 16-Slice (Air), Brilliance 64 CT…
264. Urgent Field Safety Notice for Maestro Cardiac Ablation System by Boston Scientific…
265. Safety Notice for the HeartStart FRx or HeartStart HS1 automated external defibrillators…
266. Recall for the products NOVA Biguades AF, NOVASEPT Soft Konzentrat, NOVASUC spezial…
267. Urgent Field Safety Notice for Tissue Preparation System by Hamilton Company
268. Lot recall of 6534-08N InterActive Implant Open-Tray Transfer Narrow, Implant Direct…
269. Urgent Field Safety Notice for Spectra-System/ Legacy Guided Surgery Handle Kit by Implant…
270. Urgent Field Safety Notice for OrthoScan Mini C-Arm X-Ray System by OrthoScan, Inc.
271. Recall concerning the braking and pushing aid v-max, AAT Alber Antriebstechnik GmbH
272. Urgent Field Safety Notice for STIMULAN Kit and STIMULAN Rapid Cure by Biocomposites Ltd.
273. Corrective action for the product Triathlon MIS Modular Distal Capture, Stryker…
274. Urgent Field Safety Notice for Arrow HANDS-OFF Thermodilution Catheter by Arrow…
275. Corrective action for the Heater Cooler Unit HCU 30, Maquet Cardiopulmonary GmbH
276. Lot Recall of the 27 G disposable cannula provided with the Amvisc® und Amvisc® Plus…
277. Lot recall of VIA 27 Microcatheter, Sequent Medical GmbH
278. Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS
279. Urgent Field Safety Notice for BD Microtainer Röhrchen by Becton Dickinson and Company
280. Recall for the TRACOE softpad Tracheostomy Stoma Pads, TRACOE medical GmbH
281. Urgent Field Safety Notice for optimys Rasp Handle double offset left by Mathys AG…
282. Recall for the RotaWire Elite™ Guidewire and wireClip™ Torquer Guidewire Manipulation…
283. Batch recall of Pe-Ha-Visco 10 x 2,0 % 2,0 ml Box, Albomed GmbH
284. MAGEC Spinal Bracing and Distraction System
285. da50fa8c-8f46-bdf0-7df0-35cebaa4bbdf
286. ProTime 3 Microcoagulation System Cuvettes
287. Urgent Field Safety Notice for InfectCheck NeoPT by concile GmbH
288. Urgent Field Safety Notice for 1st gen. JOURNEY BCS fem. and tib. insert componen by Smith…
289. Urgent Field Safety Notice for FTlyo diverse by Fast Track Diagnostics Luxembourg S.à.r.l
290. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
291. Recall for the ProAQT-Sensor, PULSION Medical Systems SE
292. Corrective action for mikrozid sensitive wipes, Schülke & Mayr GmbH
293. Recall of two lots of the Axxess™ Drug Eluting Coronary Bifurcation Stent System…
294. Urgent Field Safety Notice for motion cycle 600 med by emotion fitness GmbH & Co. KG
295. Corrective action for Cyclosporine (CSA) Flex reagent cartridge, Siemens
296. Urgent Field Safety Notice for CAPILLARYS IMMUNOTYPING by SEBIA
297. Lot Recall for the Revaclear® / Revaclear Max® Dialyzers, Gambro Renal Products, Inc.
298. Urgent field safey notice for Accu-Chek Connect diabetes management app version 1.2.0…
299. Additional and updated warnings and cautions for the HomeChoice Automated PD System and…
300. Millennium Oxygen Concentrator
301. Safety Information for the manyfill filling injection kits, Medex
302. Urgent Safety Notice for Camino® Advanced Monitors (CAM01), Integra NeuroSciences
303. Safety Notice for Instructions of Cerament Spine Support, Bonesupport
304. Lot Recall of the Presfit cup TiCP vitamys system, Mathys
305. Urgent Field Safety Notice for MicroVue C1-Inhibitor Plus EIA by Quidel Corporation Athens
306. Corrective action for RAPIDPoint® 500 Systems, Siemens
307. Recall for the Auxiliary Strap, SAM Medical Products
308. Batch / lot recall of i-Visc 1.6 % and i-Visc 2.0 %, i-Medical Ophthalmic International…
309. Urgent field safety notice for Syva EMIT II plus opiate assay / Dimension clinical…
310. Urgent Field Safety Notice for Infinity CentralStation, Infinity M300/M300+ by Draeger…
311. Urgent Field Safety Notice for BD MultiTEST CD3/CD8/CD45/CD4 by Becton, Dickinson and…
312. Urgent Field Safety Notice for Alcon ORA Cart with VerifEye by Alcon Laboratories, Inc.
313. Urgent Field Safety Notice for VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS by Olympus…
314. Lot Recall of the PFC® SIGMA Cruciate Retaining (CR) Cemented Femoral, DePuy
315. Urgent Field Safety Notice for VitreQ by Vitreq B.V.
316. Urgent field safety notice for Campylosel agar, bioMérieux SA
317. Urgent Field Safety Notice for Alaris/ Asena GS,GH,CC,TIVA,PK, Syringe Pumps by CareFusion…
318. Urgent Field Safety Notice for Endomina v2 by Endo Tools Therapeutics SA
319. Corrective action for the CardioCall ECG Event Recorder, Spacelabs Healthcare
320. Urgent Field Safety Notice for Medfusion Model 3500; Medfusion Model 4000 by Smiths…
321. Urgent Field Safety Notice for Fogarty Adherent Clot Catheter by Edwards Lifesciences LLC
322. URGENT IMPORTANT FIELD SAFETY NOTICE for Product Monaco, Elekta
323. Urgent field safety notice for Spiral Line ProSet, B. Braun Melsungen AG
324. Urgent Field Safety Notice for SureForm Stapler by Intuitive Surgical, Inc.
325. Urgent Field Safety Notice for Volista by MAQUET SAS
326. Urgent Field Safety Notice for Endomina v2 by Endo Tools Therapeutics SA
327. Recall for Antimicrobial Susceptibility Testing Disc, Oxoid
328. Urgent Safety Notice regarding implantable HeartWare LVAS, HeartWare Inc.
329. Safety Notice for the product GALILEI G6 Lens Professional, Ziemer Ophthalmic Systems AG
330. Recall for the blood products CompoStop and Compoflex, Fresenius Kabi
331. cobas pro
332. Field Safety Notice concerning Medumat Transport ventilator, Weinmann
333. Safety Notice concerning SOMATOM CT, Siemens Healthcare
334. Safety Corrective Action for the MIT-H® Offset Cup Impactor, WALDEMAR LINK GmbH & Co. KG
335. Urgent Field Safety Notice for 1.2 K+-Draht, Lanzette, 150mm by Medartis AG
336. Urgent field safety notice for Idylla KRAS Mutation Test, Biocartis NV
337. Synthes GmbH: Lot Recall for Drill Bit 2.0 mm drilling depth 14 mm, 3-flute for Quick…
338. Urgent Safety Notice for the ATTUNE® Intuition Distal Femoral Jig, DePuy Synthes
339. ProSet Omnifix Syringe 5ml / 10ml, B. Braun Melsungen AG
340. Urgent Field Safety Notice for EYEJET CTR by Morcher GmbH
341. Urgent Field Safety Notice for Prismaflex Sets by GAMBRO DASCO FR
342. Urgent Field Safety Notice for G4 Platinum and G5 Mobile receiver by Dexcom, Inc
343. Urgent Field Safety Notice for Philips IntelliVue Information Center iX by Philips Medizin…
344. Urgent Field Safety Notice for DISP.FLEECE DRAPE F/GA419/GD417/GD421 by Aesculap AG
345. Recall for the BIOLOX® delta TS Ceramic Femoral Articul/eze® 12/14 36mm +12 Heads, DePuy…
346. Urgent Field Safety Notice for Rusch TracFlex Plus Set, cuffed by Teleflex Medical Athlone
347. Urgent Field Safety Notice for Xenios Konsole by Xenios AG a Fresenius Medical Care…
348. e8aa5296-f419-5e40-fcfd-bff1fa9c5bf7
349. Sterile breast implants with accessories: breast implants filled with silicone gel
350. Neurosign V4
351. FreeStyle Mini® and FreeStyle® Blood Glucose Monitoring Systems
352. Urgent field safety notice for Xario 100 / 200, Toshiba Medical Systems Ltd.
353. Urgent Safety Notice for the Healon EndoCoat Opthalmic Viscosurgical Device, AMO Ireland
354. Urgent Field Safety Notice for Mojo + Mojo2+iQ 2+Phantom 2 by Sleepnet Corporation
355. Urgent field safey notice for ARGUS 717 V / ARGUS 718 V, CODAN ARGUS AG
356. Urgent Field Safety Notice for ATAR EXTENSION CABLES by Oscor Inc.
357. Urgent Field Safety Notice for Plegiox Cardioplegia Heat Exchanger by Maquet…
358. Safety Notice concerning LIVOPAN systems, Linde Gas Therapeutics
359. Safety Advisory Notice for Mammography system Mammomat Inspiration/Fusion, Siemens AG
360. Urgent Field Safety Notice for ENDOLAN Endoskop-Gleitgel 200 ml by Wolfgang Meiners…
361. Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical…
362. PadPro & R2 Multifunction Electrodes, ConMed Corporation
363. Urgent Field Safety Notice for EnSiteX EP System Amplifier by Abbott, Cardiovascular…
364. Urgent Field Safety Notice for Single Use Electrosurgical Knife by Olympus Medical Systems…
365. Urgent Field Safety Notice for SELDICATH PU EXTENSION, SELDICATH FEP, SELDICATH PTFE…
366. Corrective action for HER2 CISH pharmDX Kit, Dako
367. Urgent Safety Notice for the Philips Expression Information Portal (IP5), Philips…
368. Urgent field safety notice for Life-Point AEDs, METsis Medikal Ltd. Sti.
369. Urgent Safety Notice for Medrad® Veris® units containing main board P/N 3010641, Bayer…
370. Urgent Field Safety Notice for Pleur Evac Infant Sahara Dr. by Teleflex Medical USA
371. Urgent Field Safety Notice for Allura Xper, UNIQ, Centron by Philips Medical Systems…
372. Lot Recall of Sandel Weighted Safety Scapels, Ansell Sandel Medical Solutions
373. Recall for the product ArthroCare Ambient HipVac 50 Wand, ArthroCare Corp./Smith & Nephew
374. Urgent field safety notice for SIGNA Creator and SIGNA Explorer, GE Healthcare
375. Urgent field safety notice for MAGiC (MAGnetic resonance image Compilation) on Signa…
376. Urgent Field Safety Notice for flexiebler Katheter LLA 300-F by Eckert & Ziegler BEBIG…
377. Safety Notice for PLUM LifeCare™ 5000 Infusers, Hospira Inc.
378. Important safety notice for Use for YASARGIL Aneurysm Clips Products, Gebrüder Martin GmbH…
379. Lot Recall for the Licox® probes, GMS/Integra
380. Urgent field safety notice for Getinge ED-FLOW AER und ED-FLOW SD AER, Lancer (Getinge…
381. Corrective action for Dimension Vista® Intelligent Lab Systems, Siemens Healthcare…
382. Safety Notice concerning the List Mode Replay of the PET Discovery 610 and Discovery 710…
383. Corrective action for the CARDIOSAVE® Hybrid Intra-Aortic Balloon Pump (IABP), Maquet /…
384. Field Safety Notice for PICO70 Arterial Blood Sampler, Radiometer Medical Aps.
385. Urgent Field Safety Notice for TruCal U by DiaSys Diagnostic Systems GmbH
386. Safety Notice for the VERO™/MHI-TM2000 Linear Accelerator System, Mitsubishi Heavy…
387. Urgent Field Safety Notice for Polysorb Braided Absorbable Suture by Covidien llc
388. Lot Recall of TRIGEN INTERTAN nails, SMITH & NEPHEW
389. 5bf9b119-399b-e174-e3fa-8d83df11341d
390. Safety Notice and Recall of Lithium Ion Polymer Batteries used as componets of Companion…
391. Dummy Length Sizer for Middle Ear Implants
392. Corrective action for Syramed SP6000 Chroma and Volumed VP7000 Chroma devices, Arcomed AG
393. Corrective action for the Syringe pump green stream SY-P ARGUS 600, Firmware version 1.00…
394. Urgent Field Safety Notice for Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI…
395. Urgent Field Safety Notice for LeverEdge Contrast Injector by LeMaitre Vascular (vormals…
396. Recall for certain Split Cath III dialysis catheters, Medcomp Medical Components Inc.
397. Safety Notice for GEMINI TF 16, 64, Big Bore, TruFlight Select, GEMINI TF Ready and GEMINI…
398. Roche cobas SARS-CoV-2 & Influenza A,B – kehtetud või valepositiivsed tulemused
399. Corrective action for HbA1c liquidirect, Human
400. Recall Shuntassistent, Christoph Miethke GmbH & Co. KG
401. Corrective action for Piccolo® Lipid Panel Plus, Abaxis
402. Safety Notice for the Codman® Quad-Lock™ Sterilization Container System and/or Symmetry…
403. Urgent field safey notice for Vibe Insulin Pump, Animas UK & Ireland / Johnson & Johnson…
404. Oertli Instrumente AG: Complete recall of the product Silicone application set, sterile…
405. Urgent Field Safety Notice for Accu-Chek Insight by Roche Diabetes Care GmbH
406. Urgent Field Safety Notice for Leksell GammaPlan by Elekta Instrument AB
407. Corrective action for Analyzer 1.1.1 of the FluoroType MRSA-Kit, Hain Lifescience
408. Corrective action for Oxoid Legionella BCYE Growth Supplement, Thermo Fisher
409. Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope…
410. Lot recall of Klerpack BD Syringe Multi-Pack, Life Sciences / Ecolab Ltd.
411. Corrective action for Oxoid Legionella BCYE Growth Supplement, Thermo Fisher
412. URGENT FIELD SAFETY NOTICE for PERI-LOC Volar Distal Radius 3 Hole Plate, Smith & Nephew…
413. Corrective action for OPTI CCA-TS2 Analyzers, OptiMedical Systems
414. Field Safety Notice for AUTOGEN DR ICDs and CRT-Ds, Boston Scientific
415. Medical Device Recall for Spine-USS II Rod lntroduction Pliers, Synthes GmbH
416. Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS
417. Recall of one lot of POWERFLEX® PRO PTA Dilatation Catheter, Cordis
418. Lot recall of suction bag 584028, Sengewald Klinikprodukte GmbH
419. Urgent Field Safety Notice for Hydraulic Ureter Dilators by Teleflex Medical
420. Urgent Field Safety Notice for British standard power cord DA8K-10-14453 by SHENZSHENZHEN…
421. Urgent Field Safety Notice for British standard power cord DA8K-10-14453 by SHENZSHENZHEN…
422. Urgent Field Safety Notice for Single channel flexible endoscopes with T-Luer by Karl…
423. Recall for the ARROW® Continuous Nerve Block Needle, ARROW International Inc.
424. Urgent field safety notice for ABL90 FLEX / ABL90 FLEX PLUS, Radiometer
425. Urgent Safety Notice for the Dialog+ Haemodialysis system, B. Braun Avitum AG
426. Hemotherm
427. Molift Air 500
428. Urgent Field Safety Notice for HPS 2.0 Rod coupler by Paradigm Spine GmbH
429. Lot recall of EZIO Manual Driver, Teleflex Medical
430. Urgent Field Safety Notice for Stoffella DC Hallux Splint by Waldemar Link GmbH & Co. KG
431. Corrective action for the 1C66 Triton Smart Ankle, Otto Bock HealthCare GmbH
432. Urgent Field Safety Notice for ADVIA Centaur XPT by Siemens Healthcare Diagnostics Inc…
433. Merivaara Q-Flow surgical lights
434. Safety Notice for the product Desktop Pro™, Elekta
435. Corrective action for Schaftansatz, rund, Hartschaum 125 kg, medi GmbH & Co. KG
436. Safety Notice for the product Integrity™, Elekta
437. Urgent Field Safety Notice for Artis zee/Artis Q by Siemens Healthcare GmbH Advanced…
438. Corrective action for the product Sydney IVF PVP, William A. Cook Australia Pty Ltd.
439. Urgent Field Safety Notice for Lifeguard Trolley by ArjoHuntleigh AB
440. Urgent Field Safety Notice for verschiedene MRT-Systeme by GE Medical Systems, LLC
441. Urgent Field Safety Notice for cobas 6800 system, cobas 8800 system by Roche Diagnostics…
442. Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH
443. Urgent Safety Notice for HemoCue® Glucose 201 Microcuvettes, HemoCue AB
444. Safety Notice for Care Beds, bemag Objekteinrichtungen AG
445. Urgent Field Safety Notice for VenoTrain: micro, soft, ulcertec, cocoon by Bauerfeind AG
446. Recall of defibrillation electrode Skintact DF29N, Leonhard Lang GmbH
447. Urgent Field Safety Notice for ImmunoCAP Allergen f205, Herring by Phadia AB
448. Recall for Asept Pleural Catheder Kits and Peritoneal Catheder Kits, PFM Medical Inc.
449. Urgent Safety Notice for the Hudson RCI® Sheridan/CF® Cuffed Tracheal Tube, Teleflex…
450. Lot recall of TS100S Tubeset Standard Diego Elite, Olympus
451. Urgent Field Safety Notice for Applied Biosystems COVID-19 Interpretive Software by Life…
452. Urgent Field Safety Notice for 3M Transbond Plus Light Cure Band Adhesive Kit by 3M Unitek…
453. URGENT FIELD SAFETY NOTICE - Access CEA Reagent Kit, Beckman Coulter
454. Urgent Field Safety Notice for PROTIS Software Kit 2.0 incl Licenc by Siemens Healthcare…
455. Urgent Field Safety Notice for NOVOSYN QUICK UNDY 2/0(3)90CM HR37S by B. Braun Surgical…
456. Urgent Field Safety Notice for Percept by Medtronic Inc
457. Urgend Field Safety Notice for Double Airway Splint I and II, Websinger GmbH
458. Urgent Field Safety Notice for ADVIA® Chemistry XPT Systems, Siemens Healthcare…
459. RTHO VISION and VISION Max Analyzers for BioVue
460. Urgent field safety notice for Combur-Test / Chemstrip / ChoiceLine 10 test, Roche…
461. Urgent Safety Notice for the Stellaris PC Vision Enhancement System with Laser, Bausch &…
462. Urgent Field Safety Notice for SWISS optio jetflow by Gebr. Gloor AG
463. Urgent Field Safety Notice for SWISS optio jetflow by Gebr. Gloor AG
464. Urgent field safety notice for NeuroPort Biopotential Signal Processing System, Blackrock…
465. Urgent Field Safety Notice for Corail2 Standard Offset (ohne Kragen) by DePuy…
466. Urgent Field Safety Notice for Extracorporeal Tubing Set containing the Over-pressure…
467. Urgent Field Safety Notice for Thermo Scientific Remel Vibrio Cholerae Ogawa agglutinating…
468. Corrective Action for the BrightView SPECT, BrightView X und BrightView XCT Systems…
469. Urgent Field Safety Notice for Vanta Implantable Neurostimulator (INS) by Medtronic Inc
470. Urgent Field Safety Notice for BIOCREDIT COVID-19 Ag by Rapigen Inc.
471. Urgent Field Safety Notice for K+-WIRE 1.35 x 170 mm by Arthrex Inc.
472. Urgent Field Safety Notice for INFINITY RESECTION GUIDE ADJUSTMENT BLOCK by Wright Medical…
473. Corrective Action for the product IntelliSpace Critical Care & Anesthesia, Philips…
474. Urgent Field Safety Notice for GENTA-COLL resorb, Collagen PARASORB RESODONT Forte…
475. Corrective action for a limited number of dental implants, BIOMET 3i
476. Urgent Field Safety Notice for ProteusPLUS by IBA (Ion Beam Applications)
477. Urgent Field Safety Notice for Equinoxe by EXACTECH, Inc.
478. Corrective action for the BrightView SPECT, BrightView X and BrightView XCT Systems…
479. Important Safety Notice for the AC 2000 spring arms, Ondal Medical Systems GmbH
480. Urgent Field Safety Notice for Assayed Bovine Multi-Sera - Level 1 by Randox Laboratories…
481. Urgent Field Safety Notice for Revision RTM by AQ Solutions GmbH
482. Corrective action for the product LIAISON® Borrelia IgG, DiaSorin S.p.A.
483. Urgent Field Safety Notice for Trilogy Evo, Trilogy Evo O2, Trilogy EV300 by Respironics…
484. Getinge Maquet Cardiosave hybrid, Cardiosave rescue IABP - UUENDUS heeliumi indikaatori…
485. Urgent Safety Notice for the 3f Enable™ Aortic Bioprosthesis, Medtronic
486. Urgent Field Safety Notice for Rigid Arm Support, Standard and Large by MEDTEC, Inc. d/b/a…
487. Safety Information concerning frisbee cervical disc prosthesis, ulrich GmbH & Co. KG
488. Urgent Field Safety Notice for Exhalyzer D by ECO PHYSICS AG
489. Recall of Accessory Adapter 600525A0, MAQUET GmbH
490. LeVeen 5cm Needle Electrode
491. Urgent Field Safety Notice for Xstrahl by Xstrahl Limited - Brownhills
492. Urgent Field Safety Notice for LEGION HK TIBIAL BASE S. 5 LEFT by Smith & Nephew, Inc.,
493. SP Eye Sharps Safe Intravitreal Injection Needle
494. Urgent Field Safety Notice for Stratus® CS Acute CareTM CTNI TestPak by Siemens Healthcare…
495. Safety Notice for the Biograph mCT- and Biograph mCT Flow systems, running VG50A equipped…
496. Recall of select lots of the Amphirion® Deep PTA Balloon Dilation Catheter, Medtronic
497. Urgent Field Safety Notice for ReNew Reusable Laparoscopic Instrument Tips by Microline…
498. Hamilton Medical Hamilton C6 hingamisaparaat - seadme olekutähiste plaadi lahtitulek
499. Urgent Field Safety Notice for 5008 CorDiax HD-PAED option by Fresenius Medical Care AG &…
500. CombiSet containing Longuetten (X-Ray Gauze Swabs)
501. Urgent Field Safety Notice for Arctic Sun Temperature Management System by Medivance, Inc.
502. Healon GV
503. ed5731f7-ffee-99b5-3d22-7503fb513fea
504. Guardian™ Connect Application FSN 1, Guardian™ Connect Application FSN 2, Guardian™…
505. Aperto
506. Corrective Action regarding Unomedical a/s infusion sets comfort™, comfort™ short and…
507. Lot recall of Sagittal Blade 18.0X.97X90MM, Stryker
508. Lot recall of Tego Connector, ICU Medical Inc.