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International device safety notices

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

  1. Notification of Medtronic for the Midas Rex Legend Pneumatic System
  2. Architect i2000 system
  3. DxI 9000 Access Immunoassay Analyzer
  4. Atellica IM 1600
  5. Recall for Surgical Cutters according to Lindemann, Hager & Meisinger
  6. Further Informations for the Solysafe Septal Occluder, Swissimplant
  7. Urgent field safety notice for FOX wheelchair, INVACARE
  8. BioMerieux recalls Trypcase-soy agar + 5 % sheep blood, Mueller-Hinton + 5 % sheep blood…
  9. Recall for QUANTUM PBL, PAA Laboratories GmbH
  10. Urgent Field Safety Notice for Logiq P5 and Logiq A5 by GE ULTRASOUND KOREA, LTD
  11. Information about Panorama Patient Monitoring Network from Datascope
  12. Safety Notice for INFUSOR- and FOLFUSOR-pumps, Baxter
  13. Urgent field safety notice for VERSANT kPCR Molecular System, Siemens Healthcare…
  14. Urgent Field Safety Notice for AQUABEAM Handpiece by PROCEPT BioRobotics Corporation
  15. Urgent Field Safety Notice for MabTrack level infliximab by Sanquin Reagents
  16. Important Safety Notice for the product MOSAIQ®, IMPAC Medical Systems, Inc.
  17. Recall of the ConMed Electrosurgery System 5000 Electrosurgical Generator
  18. Safety Notice for Durom Acetabular Cup, Zimmer
  19. Recall for the Jet-X Short, Pins and Drills, SMITH&NEPHEW
  20. Urgent field safety notice for ADVIA 560 Hematology System, Siemens Healthcare Diagnostics…
  21. Urgent Field Safety Notice for Atellica IM Erythropoietin (EPO) Assay; ADVIA Centaur…
  22. Smith & Nephew recall the sterile wound dressing Opsite Post-Op
  23. Safety Notice for the Endolite 30mm Pyramid Clamp Adaptors, Blatchford Products Ltd.
  24. Safety Notice for Robotic Radiosurgery System CyberKnife, Accuray Europe
  25. Recall of the thermometer OMRON ProTemp - MC600
  26. Coloplast recalls the Contreet Non-Adhesive Foam wound dressing
  27. Information concerning a software discrepancy for use of MOSAIQ from Elekta Limited
  28. Corrective action of Roche for SnapPak
  29. Information about falsifications of the product Ccarpule
  30. Corrective action of the Advia Chemistry Systems 1200/1650 and 2400 from Bayer
  31. Safety Notice for the Clinical Chemistry Analyzer ILab Taurus Systems, Instrumentation…
  32. Urgent Safety Notice/Corrective action for Terumo® Radifocus Guide Wire M, Terumo Europe…
  33. DPC Biermann recalls Immulite Insulin
  34. Information about defective sterile packaging of OP sets („Procedure packs“) from Cardinal…
  35. Corrective action for the icotec Pedicle System (screw taps), icotec ag
  36. Corrective action of Immunotech for CD7-FITC
  37. Information for Maximo II ICD/CRT-D, Medtronic
  38. Safety Notice for the ACUSON S Family™ ultrasound systems with software version VC30A…
  39. Alinty hq Analyzer, Alinity hs Slide Maker Stainer Module
  40. Recall of the cannulated drill bits from Newdeal
  41. Corrective action for the Swing Twin Sampler II from Diamed
  42. Recall for Standard Implant, Straumann
  43. Recall of Portex Chest Drainage Systems from Smiths Medical International
  44. Recall for Argyle™ Suction Catheter, Tyco Healthcare
  45. Urgent Field Safety Notice for Codman Certas Programmable Valve System by Integra…
  46. Corrective action for the Pressure Injectable Central Venous Catheter Product…
  47. Corrective action for the Centricity PACS-IW system, GE Healthcare Integrated IT Solutions
  48. Merit Medical recalls the IntelliSystem II Thermal Dot Matrix Printer IN1600/IN1650
  49. Recall of specifiy lot numbers of the infusion device Coventry Valve Triple IV Peripheral…
  50. URGENT FIELD SAFETY NOTICE for Oasis coil extension cable, HITACHI MEDICAL CORPORATION
  51. Urgent field safety notice for Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon…
  52. Recall for Zimmer Alumina Ceramic Femoral Head, Zimmer Inc.
  53. Recall for the Medtronic Navigation Sterile Devices, Medtronic
  54. Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies
  55. Information concerning the COULTER® LH 700 series analyzer software from Beckman Coulter
  56. Urgent Safety Notice for the product AbbVie nasojejunal (NJ) tubes, AbbVie, Inc.
  57. Recall of the transfer sets manufactured by Whatman which are shipped with Berinin P…
  58. Safety notice for insulin pumps DANA Diabecare IIS, Sooil Development Co. Ltd
  59. Urgent Field Safety Notice for APERLAN POKA YOKE (Agent A & Agent B) by Getinge Lancer
  60. Safety Notice for A-dec-311-articulating headrest, A-dec Dental UK Ltd.
  61. Corrective measures on the High Flow Double-Lumen Catheter TH1420 from Fresenius
  62. Corrective action for ULTRA FAST-FIX Knot Pusher Suture Cutters, Smith & Nephew, Inc.
  63. Corrective action for the Amax Destiny Plus coagulation analyzers from Trinity Biotech
  64. Corrective action and Recall for Omni S system versions 2, 4 and 6 with CO-oximetry, Roche
  65. Recall of stimulator unit MS-210BK from Nihon Kohden
  66. Information about the Clinical Information Center (CIC) Pro from GE Healthcare…
  67. Recall Information concerning the Qufora Irrigation System, MBH-International A/S
  68. Urgent Field Safety Notice for iQ200 Elite by IRIS International
  69. Recall of Dade Behring for Dade Actin
  70. Field Safety Notice for emergency / transport ventilators Oxylog 3000, Dräger
  71. Urgent Field Safety Notice for Monnal T60 by Air Liquide Medical Systems
  72. Recall of Tosoh for AIA-600 II
  73. Baxter recalls special lots of the ALYX Component Collection System
  74. Information for bone conductors attached to audiometers, Interacoustics
  75. Gambro Industries recalls the Gambro Prisma sets for the CRRT system Prisma
  76. Corrective action for all D2RS / DX-D800 and XCELLENCE DYNAMIC devices, STEPHANIX
  77. Urgent Field Safety Notice for TANZO TOUCH TT+23 by Woson Medical Instrument Co., Ltd.
  78. Urgent Field Safety Notice for MiniMed 640G, 670G, 720G, 740G, 770G, 780G by Medtronic…
  79. Safety Notice for SYNCHRON UniCel DxC Clinical Systems - Tube Assembly 142, Beckman…
  80. Important Safety Information for the accessory part Fixed Backrest used for the Mobile…
  81. Urgent Field Safety Notice for Heater-Cooler System by LivaNova Deutschland GmbH
  82. Communication problems with accelerator software Desktop Pro from Elekta
  83. Safety Notice concerning sensor cables used with InstaTrak 3500, InstaTrak 3500Plus…
  84. Corrective action for the Tenor lift without scale, ArjoHuntleigh
  85. Urgent Field Safety Notice for EndoWrist Stapler Release Kit by Intuitive Surgical Sàrl
  86. Urgent Field Safety Notice for Avenir Muller Stem (Std./Lateral) by Zimmer GmbH
  87. Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott…
  88. Recall for Anti-Leb (Murine Monoclonal) Blood Grouping Reagent, Immucor
  89. Lot recall of CA090 Direct Drive Clip Appliers, Applied Medical
  90. Urgent Field Safety Notice for lmmuno Control Set by SENTINEL CH. SpA
  91. Information for Innova 3100 and 4100, GE Healthcare
  92. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
  93. Urgent Field Safety Notice for Plasmaprotelns Cal 3x. Plasmaproteins Cal by SENTINEL CH…
  94. Corrective action for ExacTrac Vero 3.x Patient Positioning System, Brainlab AG
  95. Recall of MEDRAD ® Continuum Pump and Tubing Set, Bayer HealthCare
  96. Recall of Roche Molecular Systems for Tina-quant D-Dimer Gen. 2, Roche Diagnostics
  97. Safety Notice for the Optima MR360/Brivo MR355 system, GE Healthcare
  98. Urgent field safety notice for 21inch monitor arm for ARIETTA 60 and ARIETTA 70, Hitachi…
  99. Recall for Berichrom Heparin, Siemens
  100. Recall of the Glidescope GVL and AVL reusable blades, Verathon
  101. Recall for Covidien Devon™ Light Gloves (also included in certain sub-assembly kits)…
  102. Corrective action for Artis zee, Artis zeego, Artis Q and Artis Q zen systems, Siemens AG
  103. Safety Notice for Leica Peloris™ Rapid Tissue Processor, Leica Biosystems Newcastle Ltd.
  104. Safety Notice on Easyband Telemetric Gastric Bands, Allergan
  105. Urgent Safety Notice for Novocastra TTF-1 Primary Antibodies, Leica Biosystems Newcastle…
  106. Recall of Tecan for 1000 μl Disposable Tips with filter
  107. Recall for Innofluor Certican Assay, Seradyn / Thermo Fisher Scientific
  108. Recall of the REFSTAR™ External Reference Patches from Biosense Webster
  109. Safety instructions for 3D Spacecurl, Physio Börse Anatomie & Therapie
  110. Information for ReFacto AF Laboratory Standard, Wyeth
  111. Urgent Field Safety Notice for MAS ChemTRAK H Assayed Control Level 3 by Microgenics…
  112. Safety Notice for BrachyVision, Varian Medical Systems
  113. Urgent field safety notice for cementless Oxford partial knee unicompartmental knee…
  114. Lot Recall for Alpha Inlays, Zimmer
  115. Corrective action for Dual mobility acetabular cup SATURNE®, Amplitude GmbH
  116. Urgent Safety Notice for the Jasmine Mobile Lifter - Mast Connector, Invacare
  117. Urgent Field Safety Notice for ACUSON SC2000 by Siemens Medical Solutions USA, Inc…
  118. Recall for BD Vacutainer 2.7 ml Plus Citrate Blood Collection Tube, Becton Dickinson
  119. Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc…
  120. Information about E.motion components from the manufacturer Aesculap AG
  121. Recall for the Endoplege Coronary Sinus Catheter Kit, Edwards Lifesciences
  122. Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG
  123. Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG
  124. Information for cobas e 411 software, Roche
  125. Recall for VITEK 2 60 and VITEK 2 XL, Biomerieux
  126. Another Safety Notice concerning Series Unique Identifier (UID) issue associated with MR…
  127. Urgent Field Safety Notice for Infiniti Bracket by CIVCO Medical Instruments CO
  128. Lot recall of drill bit f. quick coupling; Ø3.2 x 160 / spiral In 60 / quadr. spiral /…
  129. Recall of Rad 9 Pulse Oximeters from Masimo
  130. Corrective action for the Philips Model AFFINITI 70 Ultrasound System, Philips Healthcare…
  131. Information for A3-tube-connector, Bauerfeind AG
  132. Information for DS2 automated microplate processing system, MHRA
  133. Urgent Field Safety Notice for Medical devices for lipofilling by Groupe Sebbin SAS
  134. Recall of Hedstrom Files from Kerr Hawe
  135. Lot Recall for the implant Impla Mini balltop 2,5/9,5 mm, Schütz Dental GmbH
  136. Recall for AMO TECNIS® CL Foldable Silicone IOL with OptiEdge Design, AMO Ireland
  137. Corrective action of Dade Behring for Complement Reagents
  138. Inspection of the trolley chassis of the Fabius GS anaesthesia devices from Dräger
  139. Urgent field safety notice for ADVIA chemistry systems and Dimension clinical chemistry…
  140. Information for Lifepak CR Plus defibrillator / Lifepak Express defibrillator, Medtronic
  141. Urgent Field Safety Notice for EnFlow by CareFusion 211 Respiratory Systems
  142. Corrective action of the Infinity™ Ammonia Liquid Stable Reagent from Thermo Fisher…
  143. Recall for SYNCHRON Acetaminophen Reagent (ACTM), Beckman Coulter
  144. Safety Notice concerning CombiSets® containing Medtronic Covidien Devon™ Light Glove, Paul…
  145. Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare
  146. Safety Information for ceramic Biolox cup, Aesculap
  147. Urgent Field Safety Notice for Delta/Delta XL/Kappa by Draeger Medical Systems, Inc
  148. Baxter recalls certain lot numbers of the 6060 Solution sets
  149. Recall for the Dade Actin Activated Cephaloplastin Reagent (Lot-Number 537148) of Dade…
  150. Information concerning the X-ray systems Allura Xper FD20/10 and FD20 with Smart Mask…
  151. Corrective action for the HEMOSPRAY ENDOSCOPIC HEMOSTAT, Cook Medical Europe
  152. Corrective action for the Philips Ultrasound EPIQ 7 Ultrasound System, Philips Healthcare…
  153. Urgent Field Safety Notice for BORA and KITE by Invacare Deutschland GmbH
  154. Safety Notice for DePuy's cemented polished CoCr alloy femoral hip stems combined with MoM…
  155. Urgent field safety notice for Pleural Drainage System, Teleflex Medical
  156. Urgent Field Safety Notice for Ingenuity Flex Ingenuity CT Ingenuity Core Ingenui by…
  157. Urgent Field Safety Notice for MELAdes 800, MELAdes 801 by Melag oHG Medizintechnik
  158. Field safety notice to iSite PACS
  159. Urgent Safety Notice for various Pins, Wires and Drill Bits, Smith & Nephew
  160. Urgent Field Safety Notice for VIDAS FSH by bioMérieux S. (Marcy- l'Etoile)
  161. Risk when using the syringe pump Asena from Alaris Medical Systems
  162. Recall for ECMO-Cannulae EKA 88 M, Maquet
  163. Information for Neonatal Soft Venous Reservoir, Sorin Group
  164. Recall for Ambix activ ambulatory Set and Ambix activ stationary Set, Fresenius Kabi
  165. Recall for the Oasys Midline Plates, STRYKER
  166. Recall for 500ml Canister/InfoV.A.C., KCI
  167. Recall for arterial catheterisation sets with incorrect assembled introducer cannulas…
  168. Recall of the silicone oil tamponade RT SIL-OL 5000, Carl Zeiss Meditec AG
  169. Recall of the product Removable T-Handle
  170. Recall for Vitesse Biopsy needle, OptiMed
  171. Encore Medical recalls Foundation and 3DKnee Non-Porous Baseplates
  172. Information for Protis CSF and Kidney Assessment Kit, Siemens Healthcare
  173. Recall for Targon TX Access Reamer, Aesculap
  174. Recall of Stöckert Venous Cannulae
  175. Corrective action for ProC Global, Dade Behring
  176. Urgent Field Safety Notice for DIPHOTERINE - PREVIN by PREVOR
  177. Safety Notice for the Philips Model AFFINITI 50 Ultrasound System, Philips Healthcare…
  178. Urgent Safety Notice for the Philips EPIQ 5 Ultrasound System, Philips Healthcare…
  179. Safety Notice for iPlan RT Dose version 4.0, BrainLAB
  180. Urgent Field Safety Notice for Elekta Unity by Elekta Ltd
  181. Recall of Dade Behring for N Latex SAA OQMP
  182. Recall of tangoRS-spinal instrumentation systems from Ulrich
  183. Problem with MLC and field size changes to XiO plans, Elekta CMS software
  184. Safety Corrective Action for Hudson RCI®Humidifier Adaptor for use with Aquapak®, Teleflex
  185. Field Safety Notice for training device Diagnos med
  186. Urgent Safety Notice for Keeler Cryomatic Probes, Keeler Ltd.
  187. Recall of the products „Legion Offset Coupler Trials“ from Smith&Nephew
  188. Recall for Columbus gliding surface/tibial insert of the article NN340 and NN222, Aesculap…
  189. Safety Notice for EverFlow Dolphin Protect hemodialysis catheter, Gambro
  190. Safety Notice for SharePlan 1.1, RaySearch Laboratories
  191. Urgent Field Safety Notice for Wundhaken Richardson, Wundhaken Kelly by Rudolf Medical…
  192. Information for GEM Check Coag Whole Blood Controls, Instrumentation Laboratory
  193. Urgent Field Safety Notice for D-Vapor; D-Vapor 3000 by Drägerwerk AG & Co. KGaA
  194. iPlan RT Dose
  195. Recall of the Cell-Dyn 22 Calibrator from Abbott
  196. Safety Notice for the Optical Guidance Platform (OPG) Software, Varian medical systems
  197. Urgent Field Safety Notice for Bohrloch Reservoir Set by Christoph Miethke GmbH & Co. KG
  198. Urgent Field Safety Notice for Alinity s System by Abbott GmbH
  199. Information for Diagnost systems, Philips
  200. Corrective action for the AxSYM Myoglobin Reagent Kit from Abbott
  201. Corrective action for the product AMICA Probe, HS Hospital Service SpA
  202. Urgent field safety notice for TELITHROMYCIN 15UG / TEL15C, Mast Group Ltd.
  203. Urgent Field Safety Notice for Meddstone by Stille AB
  204. Break in communication between the Desktop Premium Therapy software from Elekta and its…
  205. Important Safety Notices concerning the Pari inhalers from Pari
  206. Urgent Field Safety Notice for Ventrikelkatheter by Christoph Miethke GmbH & CoKG
  207. Field Safety Notice about possible interference between the CentriMag Blood Pump and the…
  208. Smith Medical recalls several Deltec Administrations Sets
  209. Deficiency of bloodline systems for haemodialysis-A/V sets from B.Braun
  210. Recall for Vitros Chemistry Products PHBR Slides, Ortho Clinical Diagnostics
  211. Urgent Field Safety Notice for Aqua Sense III-130 PAL by Aaren Scientific Inc.
  212. Olympus EZ1500 series endoscopes - tarkvara uuendamine varasemate probleemide…
  213. Urgent field safety notice for Brilliance BigBore Oncology CT / Brilliance BigBore…
  214. Recall of the Smith & Nephew products Remove and Skin-Prep wipes that are co-packaged in…
  215. Important Safety Notice for the product Oxylog 2000 Breathing Hose, Dräger
  216. Recall of burs, irrigation instruments etc. from ConMed Linvatec
  217. Safety Notice for the Terumo Advanced Perfusion System 1, Terumo Cardiovascular Systems
  218. Recall of DPC Biermann Immulite 2000 and 2500 Cortisol and Immulite 2000 Folic acid
  219. Recall for UniCel DxI Access Immunoassay Systems Reaction Vessels, Beckman Coulter
  220. Recall for central venous catheter, Teleflex Medical
  221. Urgent field safety notice for ADVIA Centaur CP, Siemens Healthcare Diagnostics Inc.
  222. Recall of Bush DL / SL ureteral illuminating catheter set, Cook Medical Europe
  223. Corrective action for the Palindrome™ Precision SI Chronic Catheter, Palindrome™ SI…
  224. Recall of Clinical Chemistry Phenobarbital from Abbott
  225. Recall of Caeruloplasmin NL BINDARID Radial Immunodiffusion Kits from The Binding Site
  226. Recall FloSeal Endoscopic Applicators, Baxter
  227. Safety Notice for XiO: Incorrect Entry of Electron Density Data for Proton Dose…
  228. Urgent field safety notice for Artis zee systems with SW VD 11 and A100 generator, Siemens…
  229. Recall for the DYONICS POWER Synthes Chuck, Smith&Nephew
  230. Corrective action for tests based on Trinder Reaction, Roche
  231. Important Notice for Quick-Type TM for Lifematch TM Update CD, Tepnel Lifecodes
  232. Safety Notice for DYONICS BONECUTTER ELECTROBLADE, Smith & Nephew
  233. AGA Medical Corporation recalls AMPLATZER® Delivery Systems and AMPLATZER® Exchange…
  234. Recall for PlasmaKinetic SuperSect™/PK SuperSect Instrument, Olympus
  235. Urgent Field Safety Notice for Certofix Quattro by B. Braun Melsungen AG
  236. Safety Notice for the Xeno wheelchair, Otto Bock
  237. Tyco recalls the Shiley FlexTra Tracheostomy Tubes
  238. Information for Clinical Chemistry Bilirubin Calibrator and Clinical Chemistry Total…
  239. 3M Surgical / 3M Specialty Clipper Blades
  240. Safety Notice for AXIOM Artis U, Siemens Healthcare
  241. Exchange of fastening elements in the carrying chair model ALS 400 from Utila
  242. Recall of Footrest vacuum pumps, AB Germa
  243. Corrective action of Ortho-Clinical Diagnostics for Vitros CRP Microslides
  244. Revision of the instruction for use for wheelchair backs Jay2 and Jay 2 Kontur…
  245. Corrective action for the LeukoSure Enumeration Kit, Beckman Coulter
  246. Urgent Safety Notice for the product Remel PathoDx Strep B Group Latex, Remel Inc. (Part…
  247. Recall of Biotrin for Parvovirus B19 Immunofluorescent Assay
  248. Safety Notice for the wheelchair Permobil C500 Corpus Lowrider, Permobil
  249. Dimension Vista Mass CKMB Isoenzyme Calibrator
  250. Corrective action for the FC 500 with CXP Acquisition Software of Beckman Coulter
  251. Recall for gabControl Troponin I (M04K13) and gabControl CardiaCombo…
  252. Field Safety Notice concerning Hologic StereoGuide Biopsy System, Medicor
  253. Urgent Field Safety Notice for Diphtheria Toxoid IgG Enzyme Immunoassay Kit by The Binding…
  254. Boston Scientific recalls detachable coils GDC
  255. Recall for M5066A / M5068A HeartStart OnSite and HS1
  256. Recall for Targeting Guide Instruments - Zimmer Natural Nail System, Zimmer Inc.
  257. Software failure of CIC Pro Central Stations from GE Medical Systems
  258. Recall of different Amplatzer® Devices from AGA Medical
  259. Information for syngo Dynamics Reporting System, Siemens
  260. Recall of Frazier Sauger 3 mm / Länge 200 mm-SUGGF3533, Yellow's Medical Instruments GmbH
  261. Information for Exact Couch Top
  262. Urgent Field Safety Notice for ON-X Prosthetic Heart Valve ONXA by CryoLife, Inc.
  263. Corrective action for the NOxBOXi Inhaled Nitric Oxid Delivery and Monitoring Device…
  264. Urgent field safety notice for BrightView / BrightView X, BrightView XCT, Philips Medical…
  265. Information concerning all Treatment-versions 8.0.15 and below from Varian
  266. Safety Notice for AED 10 and MRL JumpStart, Welch Allyn
  267. Urgent Field Safety Notice for Merit Procedure Packs (incl. Original Perfusor Line…
  268. Change of the German instruction for use for the TEC-5500 from Nihon Kohden
  269. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
  270. Recall of Dade Behring for Dimension N-Terminal Pro-Brain Natriuretic Peptide Calibrator
  271. Recall for M3535A/M3536A HeartStart MRx, Philips
  272. Corrective action for the products global® total® LGGT-030, LGGT-060, global® total® w/…
  273. Safety Notice for the Philips DigitalDiagnost 4.0.x, Philips Medical Systems
  274. Recall for reagent STA-Neoplastin Plus, Diagnostica Stago
  275. Information for K-Tips, Roche
  276. Boston Scientific recalls the MAVERIK™ Monorail™ catheter
  277. Information for PROSTIVA RF Model 8929, Medtronic
  278. Urgent Field Safety Notice for Infusomat Space Line Type Transfusion by B. Braun Melsungen…
  279. Safety risk of the birthing beds models Birthright 35000 and 170000 from Huntleight…
  280. Safety Notice for HLA B27 FITC-Conjugated Monoclonal Antibody, One Lambda, Inc.
  281. Urgent Field Safety Notice for Anti-Xa by Roche Diagnostics GmbH
  282. Field Safety Notice concerning a problem with Prowess Panther Treatment Planning System…
  283. Corrective action for Coulter AcT diff 2 hematology analyzers, Beckman Coulter
  284. Information about Lithostar Modularis Vario from Siemens Medical Solutions
  285. Recall for GEM TEST PT Cartridges, Instrumentation Laboratory
  286. Corrective Action for oneHbA1c FS / oneHbA1c IS, DiaSys
  287. Urgent Field Safety Notice for TRACOE comfort by TRACOE medical GmbH Nieder-Olm
  288. Inspection of older lots of Autotransfusion System Transmed Haem-o-Trans from Sarstedt
  289. Recall of three lots of Laryngoscope Handles “Safescope”, Vygon
  290. Modification and replacement of instruction for use of Vortek Single loop Ureteral Stents…
  291. Urgent field safety notice for LiquiBand® FIX8™, Advanced Medical Solutions
  292. Corrective Action for Biometer Lenstar LS 900, Haag Streit AG
  293. Asid Bonz GmbH: Safety Notice for the product Aerosol nebulizer with mask, adult
  294. Safety Notice for SureSigns Patient Monitors and Vital Signs Monitors VM4, VM6, VM8, VS3…
  295. Safety Notice concerning a corrective action of the Philips Invivo Expression MRI Patient…
  296. Urgent Safety Notice for the 43-TRL-Inserter, Pioneer Surgical
  297. Urgent Field Safety Notice for AquaPak 340 ml by Teleflex Medical Morrisville
  298. Recall of one lot of the contact lens care solution OptiStar 2
  299. Lot Recall for DIRECT DRIVE GRASPERS, Applied Medical
  300. Corrective action of Abbott for Murex HSV
  301. Information about a software update of Acuson Antares and Sonoline Antares ultrasound…
  302. Urgent Field Safety Notice for LactoSorb RapidFlap by Biomet Orthopaedic LLC
  303. Urgent Field Safety Notice for RYTHMIC EVOLUTION by MICREL MEDICAL DEVICES SA
  304. Recall of Genzyme Virotech for Treponema pallidum IgM Ecoline Testkits
  305. Recall of the RAPIDFILL Syringe Strip for use with the RAPIDFILL Automated Syringe Filler…
  306. Lot Recall for Atlas PTA Balloon Dilatation Catheters, Bard Limited
  307. Masimo informs about a battery charge of the Radical Handheld of SET Pulse Oximeter
  308. Corrective action for the Acetaminophen assay, Sekisui Diagnostics P.E.I. Inc.
  309. Recall of Peri-Loc and TC-100 bone screws from Smith & Nephew
  310. Recall of CT Exprès Contrast Injection Systems "Temperature Maintainer Modell", Bracco…
  311. Urgent Field Safety Notice for IMRIS Operating Room Tables by Deerfield Imaging, Inc.
  312. Safety Notice for Hi-Art System, TomoTherapy
  313. Urgent Field Safety Notification / Increased Risk of Cardiovascular Death with Adaptive…
  314. Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH…
  315. Stryker recalls the StrykeFlow 2 pump and Handpiece with 10 feet of Tubing
  316. Safety Notice for Stereotactic Positioner, GE Healthcare
  317. Urgent Field Safety Notice for IMRIS Operating Room Tables by Deerfield Imaging, Inc.
  318. 216dd0fa-3c87-89db-9e4f-a9ec3b573cbe
  319. Safety Notice for ImageServer/xd,Sectra Imtec AB
  320. Safety Notice for MX 8000 IDT 16, Philips
  321. Corrective Action for the da Vinci Si Surgical System, Intuitive Surgical
  322. Recall for SHER-I-SWIV and SHER-I-BRONCH, Teleflex Medical
  323. Recall for formoline L112, Certmedica
  324. Safety Notice for Ventri, GE Medical Systems
  325. Urgent Field Safety Notice for Fully Automated Urine Particle Analyzer UF-4000 / Fully…
  326. Recall of Remel Europe for Wellcogen Bacterial Antigen Kit
  327. Recall for Wiseguide™ Guide Catheters, Impulse™ and Expo™ Angiographic Catheters, Boston…
  328. Safety Information for Instrument hoses of Planmeca Compact dental unit, PLANMECA OY
  329. OrbusNeich recalls the SafeCut Coronary Dilatation Catheter
  330. Recall of several models and lot mumbers of the Arthro-Knife, ConMed Linvatec
  331. N Latex Free Light Chain lambda
  332. CT System Workstation
  333. Recall of IntrepideTM coronary stent system, ClearStream
  334. Urgent Field Safety Notice for Leica Biosystems Cryostats by Leica Biosystems Nussloch…
  335. Safety Notice for MX8000Dual v. Exp., Philips
  336. William Cook recalls some tracheostomy-sets
  337. Information for TotalCare Duo2, Hill Rom
  338. Recall for the product TRACOE vario Tracheostomy Tube, TRACOE medical GmbH
  339. Otto Bock recalled the powered wheelchairs C1000 and B600
  340. Lot Recall of Endosgel 11 ml, Farco-Pharma
  341. Urgent Safety Notice for the Philips CT Brilliance series and Ingenuity CT scanners…
  342. Urgent field safety notice for Duraloc Option LPW Poly Inserts, DePuy Synthes
  343. Potential therapy failure of Sigma pacemakers from Medtronic
  344. Information concerning a replacement of the external N-AC power units with serial number…
  345. Corrective action for UniCel DxH 800 Coulter Cellular Analysis System, Beckman Coulter
  346. DePuy Orthopaedics recalls the Acclaim Total Elbow Joint Replacement Implant
  347. Recall of the AED 20 defibrillators from Welch Allyn
  348. Corrective action for the Accu-Chek® Mobile blood glucose monitoring system, Roche…
  349. Safety risk in the wheel suspension of the three-wheeled chair Cheetah from R82
  350. Information concerning two defects in Datex-Ohmeda S/5 iCentral software version L-NET05…
  351. Recall for Dimension Total Bilirubin (TBIL) Flex reagent cartridge (Lot-Number FC8170) of…
  352. Corrective action and recall for Dimension RxL Max / Xpand Plus Software Version 7.4 und…
  353. Safety Notice for Siroclave S, Sirona
  354. Urgent Field Safety Notice for Trinity, Ceramic Biolox Delta Liners and Heads by Corin…
  355. Information ClosureFAST™ catheter, VNUS Medical Technologies
  356. Safety Notice for Access® Immunoassay Systems SHBG, Beckman Coulter
  357. Recall of Arm positioning devices (1001. 44CO/DO/EO/FO) and Elbow support devices (1004…
  358. Expanded Recall Information for Vicryl Rapide, Ethicon
  359. Safety Notice for WaveScan Offline Programming Module (OPM), AMO Germany GmbH
  360. Safety Notice concerning the Datex/GE compatible SpO2 sensor model S100A-300011, Solaris…
  361. Urgent Safety Notice / Corrective action for Centricity PACS RA1000 Workstation versions…
  362. Chargenrückruf für 1 ml Medallion® Spritzen, Merit Medical Inc.
  363. Recall of the Pressure transducers DPT 8003 from Codan pvb Critical Car GmbH
  364. Safety Notice for iVue100, Optovue
  365. Recall for the product Dermaroller MC, Dermaroller GmbH
  366. Urgent Field Safety Notice, IMC-15-11.A.OUS, IMMULITE® 2000, IMMULITE® 2000 XPi Italian…
  367. Recall for Sonopet Ultrasonic Aspirator Console, Stryker
  368. Urgent Field Safety Notice for Access 2 Immunoassay Analyzer (Refurbished), Access 2…
  369. Information concerning the shower-commode chairs model Bonn and Berlin from Rebotec
  370. Recall: Self-Tapping Screw Module used with the ATLANTIS Anterior Cervical Plate System…
  371. Synthes GmbH: Safety Notice for the Orbital Rim Plate, 1.3 curved, 9 holes, Pure Titan
  372. Recall for QuantiFeron-TB Gold TB Antigen Tubes, Cellestis
  373. Urgent field safety notice for 360 TIBIAL AUGMENT, Biomet UK Ltd. / Zimmer Biomet
  374. Delphin
  375. G-6-PDH Normal Control Kit
  376. Venture Catheters
  377. PU Support Pads
  378. 3fbe2174-a31d-80e2-7052-73384d34f754
  379. Boule Medical Swelab Alfa, Alfa Plus Sampler automaatse vöötkoodilugejaga - võimalik…
  380. Idylla BRAF Mutation Test
  381. ThomoTherapy HI Art treatment system
  382. Vamp Optima
  383. Medtronic Inc. Active SC, Pocket Adaptor for Deep Brain Stimulation - A610 asendustöövoog…
  384. EMBOL-X Glide Protection System
  385. Siemens Healthineers Epoc Blood Analysys System Host2 - seadme hangumiseoht…
  386. BioFire® FilmArray® Blood Culture Identification Panel
  387. EMBLEM S-ICD Programmer
  388. Artis Q / Q.zen / pheno / icono
  389. Atellica IM CKMB MCM
  390. Bio-Rad DiaClon Rh-Subgroups + K - teise komponendiga koostoime tõttu võimalikud…
  391. Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64, Brilliance Big Bore, Brilliance…
  392. Kaliumzusatzlösung für Hämodialysekonzentrate
  393. TraumaDiagnost
  394. BIOFIRE Pneumoniaplus (PNplus) Panel
  395. BD FACS Sample preparation Assistant II Instrument
  396. BD Difco Shigella Antiserum Group C1
  397. Stryker Trauma Stretcher
  398. Medtronic MiniMed 600 series insulin pumps - katkise või puduuva kinnitusrõngaga seadme…
  399. THIOGLYCOLATE BROTH+RESAZURIN
  400. Medtronic MiniMed 600 and 700 series insulin pump - patareikork võib lahti tulla
  401. Exelia VP
  402. RadiForce
  403. Intermate Filling Set
  404. Access 2 Immunoassay Analyzer / Access 2 Immunoassay Analyzer, Refurbished / Access 2…
  405. Bard Peripherally Inserted Central Catheter (PICC) and kits
  406. S/5 iCentral
  407. mySugr GmbH Bolus Calculator - vajalik tarkvarauuendus
  408. Advantage and Advantage Fit System
  409. da Vinci S/Si and X/Xi EndoWrist Clip Applier Instruments
  410. Infinia
  411. Gibeck Humid-Vent Filter Compact S with Flex Tube
  412. DEBARCOUL90.02
  413. lntraCiude Intra-Aortic Occlusion Device
  414. Recall of ECO process in Miele / Olympus ETD washer-disinfectors
  415. Recall for the Gyrus ACMI Diego Elite Tubeset, GYRUS ACMI, Inc. (Olympus)
  416. Safety risk with the BINGO mobility base from Hoggi
  417. Lot recall of UrgoClean Ag, URGO GmbH
  418. Safety Notice for IntelliVue Patient Monitors, Philips
  419. Recall for Lightwave Suction Ablators, ConMed Linvatec
  420. Urgent field safety notice for ETEST OX 256 (OXACILLIN), bioMérieux SA
  421. Corrective action for Precision Xceed blood glucose monitoring products from Abbott
  422. Recall for the ADVIA Chemistry A1c Calibrator, Siemens
  423. Lot Recall for the MultiLoc Proximal Humeral Nail, SYNTHES
  424. Corrective action for syngo® RT Dosimetrist version 2.7 - Software Update, Siemens AG
  425. Urgent Field Safety Notice for one HbA1c FS/ one HbA1c IS by DiaSys Diagnostic Systems…
  426. Urgent Field Safety Notice for Atellica UAS 800 Analyzer, Atellica 1500 Automated…
  427. Recall for Auto D Dimer Kit, Trinity Biotech
  428. Recall of the Arctic Circler® Linear Cardiac Cryoablation Catheter from CryoCath…
  429. Recall for SteriChek Sensitive Total Chlorine Reagent Strips, Hach Company
  430. Lot recall for 1•Day Acuvue® TruEye™, Johnson & Johnson Vision Care
  431. Recall for the Chisel Blade, Synthes GmbH
  432. Risk with the Prisma 2K from Siemens
  433. Safety Notice for the AnyScan S, SC, SCP products, Mediso
  434. Corrective action for SSP Kit DPB1, Olerup
  435. Corrective Action for Responder 2000 Defibrillator, MDSS
  436. Corrective action for CODAN I.V.STAR® F 5 Set - 0,9/2,0 mm (ID/OD)(FLL, MLL), CODAN…
  437. Corrective action for the Getinge 86-series washer-disinfectors, Getinge Disinfection AB
  438. Ethicon Endo-Surgery recalls specific lots of the Endopath 5 mm and 10 mm instrument with…
  439. Urgent Safety Notice for the product PTW UNIDOS webline Typ T10021, T10022 und T10023…
  440. Lot recall of INFASID®-P plus 190, ASID BONZ GmbH
  441. Recall of the connector cable component of the GYNECARE VERSAPOINT Bipolar Electrosurgery…
  442. Recall for Ultrapower Diamond Wheel burs, ConMed Linvatec
  443. Recall for Synchron Systems Modular Creatinine (CREm) Reagent Kits, Beckman Coulter
  444. Recall for the product BVI CustomEyes® Ophthalmic Procedure Kits, Beaver-Visitec…
  445. Information for Telemetry Reciever Model 90478, Spacelabs Healthcare
  446. Corrective action for the products Bondek and Tevdek, Teleflex Medical
  447. Information for Infinia Hawkeye and Infinia Hawkeye 4, GE Healthcare
  448. Falcon Medical recalls the Varicon hip prosthesis
  449. Updated Safety Notice / Recall for the ABGII Modular Systems, Stryker
  450. Urgent field safety notice for oneHbA1c IS INNOVASTAR, DiaSys Diagnostic Systems GmbH
  451. Urgent field safety notice for Absorb and Absorb GT1 bioresorbable vascular scaffold (BVS)…
  452. Corrective Action of Abbott for Architect B12
  453. Corrective action for the adjustable positioning elements, MAQUET GmbH
  454. Corrective action of BioMerieux for ID 32, Rapid ID 32, Rapid ATB and ATB identification…
  455. Recall of the Identity family of pacemakers from St. Jude Medical
  456. Urgent field safety notice for Vivid E95/E90/E80 with software version 201, revision 54.0…
  457. Corrective action for the Ingenia, Intera, Achieva and Multiva MR Systems using R5.1 .1…
  458. Recall of recomScan Version 3.4, Build-Versionen below 62, MIKROGEN GmbH
  459. Recall of VarioFit Classic cementfree hip prostheses, aap Implantate AG
  460. Recall of Vitros Chemistry Products Lipa Slides Gen 48 Coating 3235 with lot number…
  461. Corrective action for the RN synOcta Abutment H2.5mm, Institut Straumann AG
  462. Urgent Field Safety Notice for 17° Multi-Unit Abutment CC NP 2.5mm by Nobel Biocare AB
  463. Lot-Recall for „blend-a-dent Super-Haftcreme extra stark und frisch“, PROCTER & GAMBLE
  464. Urgent field safety notice for ThinPrep 5000 Processor with Autoloader, Hologic Inc.
  465. Customer Information for several products of Thomashilfen GmbH
  466. Corrective action for the "ReNew Fenestrated Grasper Forceps Tips", Microline Surgical
  467. Increased risk of cardiovascular death with use of ASV therapy (Weinmann devices SOMNOvent…
  468. Urgent field safety notice for Solus Flexible - small paediatric, wire-reinforced…
  469. URGENT - Field Safety Notice - Use of auto servo ventilation (ASV) devices on patients…
  470. Urgent field safety notice for cobas EGFR Mutation Test v2 CE-IVD, Roche Diagnostics
  471. Urgent Field Safety Notice for Diamond burr with coarse and extra-coarse grain (pursuant…
  472. Field safety notice from BrainLAB
  473. Safety Notice for Sequencer used with the LANTIS Oncology Information System, Siemens…
  474. Urgent Field Safety Notice for DxTerity Diagnostic Catheter by Medtronic Inc
  475. Corrective action of Biomet for Optivac® Vacuum Mixing System
  476. An anomaly has been identified in Eclipse and Vision from Varian Medical Systems
  477. Lot recall of orthodontic brackets Spirit MB, ORMCO
  478. URGENT - Field Safety Notice Philips Model AFFINITI 70 Ultrasound System, Philips
  479. Further Information about iViewGT 3.4 Service Pack 2 (SP2), Elekta
  480. URGENT - Field Safety Notice Philips Model EPIQ 5 Ultrasound System, Philips
  481. Recall for Medi-Vac Non-Conductive Suction Tubings, Cardinal Health
  482. Corrective action for the Philips Model EPIQ 7 Ultrasound System, Philips Healthcare…
  483. Notification of issues with the Accura System for Blood Filtration from Baxter
  484. Recall for CellSearch® Circulation Tumor Cell Kit, Ortho Clinical Diagnostics
  485. Corrective action for the Philips Ultrasound AFFINITI 50 Ultrasound System, Philips…
  486. Safety Notice for TactiCath, Endosense
  487. Safety Notice for DigitalDiagnost with software version 2.x and stitching option, Philips…
  488. Information concerning the GENIUS dialysis system from Fresenius Medical Care
  489. Recall of screws of the JAVA-system from Abbott Spine
  490. Lot Recall for the the device “Apex Knee System Tibial Base Plate", OMNIlife science
  491. Corrective action for the HeartAttendant Interface Cable, ReliantHeart Inc.
  492. Urgent Field Safety Notice for HANDLE THA LATERAL by Aesculap AG
  493. Safety Notice for Varian Treatment, Varian Medical Systems
  494. Urgent field safety notice for the SynchroMed® implantable infusion pump, Medtronic GmbH
  495. Updated Information for the Arthrex Power System 600, Sagittal Saw Blades, Arthrex GmbH
  496. Recall of resorbable plugs CERAPLUG gel, CERAVER
  497. Philips informs that patients should not be placed in a sitting position on the footrest…
  498. Corrective Action for One Touch Basic / Profile and One Touch Ultra of Lifescan
  499. Corrective action for the product Enzygnost Syphilis, Siemens
  500. Corrective Action for OxiMax™ N-65 Handheld Pulse Oximeters and OxiMax™ N-560 Pulse…
  501. Urgent Field Safety Notice for Entroy Patientenlifter by Arjo Hospital Equipment AB…
  502. Urgent Safety Notice for the Hospira GemStar Family of infusers, Hospira Inc.
  503. Urgent Field Safety Notice for Optilite Beta-2-microglobulin Urine Kit by The Binding Site…
  504. Baxter recalls the Intercept BC Platelet Pooling Set and Buffy Coat Pooling Set
  505. Urgent Field Safety Notice for Anti-Zika-Virus-ELISA (IgG) by EUROIMMUN Medizinische…
  506. Information concerning the High Energy Clinacs from Varian
  507. Urgent field safety notice for VITROS 3600 and VITROS 5600 Systems, Ortho-Clinical…
  508. Recall of ambIT pump cassettes from Sorenson
  509. Lot Recall for CD Horizon Legacy Multi-Axial-Screws and Vertex Cortical Screws, MEDTRONIC
  510. Urgent Safety Notice for the DuraDiagnost 3.0/4.0 X-Ray System, Philips Healthcare…
  511. Urgent Field Safety Notice for cobas 8000 by Hitachi High-Technologies Corporation

About this dataset

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1