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· 2015.08.31 Corrective action for the LX3 Microscope Floor Stand, Alcon Laboratories Inc.
Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes) PDF328KB
· 2015.08.31 Urgent Safety Notice for the chromID™ S. aureus range products, bioMérieux
In-vitro diagnostics - microbiological products PDF375KB
· 2015.08.31 Corrective action for the M6 supply unit, Gebrüder Martin GmbH & Co. KG - KLS Martin Group
Surgical equipment/ Anaesthesia - surgical equipment PDF3MB
· 2015.08.31 Corrective action for the BRAHMS Fast Screen pre I Plus, BRAHMS GmbH (part of Thermo Fisher Scientific)
In-vitro diagnostics - equipment / products for clinical chemistry PDF3MB
· 2015.08.31 Corrective action for the Aequalis IM Nail Targeting Jig, Tornier Inc.
Medical instruments for use in humans - bone surgery PDF1MB
· 2015.08.31 Safety Information for the Invacare Dolomite rollators, Invacare Rea AB
Orthopaedic / Rehabilitation technology - daily living aids PDF213KB
· 2015.08.31 Safety Notice for the ACUSON SC2000 ultrasound systems, Siemens Medical Solutions USA, Inc.
Ultrasonics - ultrasonic diagnostic equipment PDF6MB
· 2015.08.31 Recall for the VFI Pack for Silicone Oil syringes, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
ophthalmological technology - liquid media for ophthalmological purposes PDF237KB
· 2015.08.27 Corrective action for the syngo RT Oncologist™ with software version 4.2.X or 4.3.X, Siemens AG
Radiotherapy / Radiation protection - radiotherapy treatment planning systems PDF25KB
· 2015.08.27 Another Safety Notice regarding the Centricity PACS IW with Universal Viewer Version 5.0 and Centricity Universal Viewer Version 6.0 products, GE Healthcare
Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine PDF332KB
· 2015.08.27 Safety Notice for the Centricity PACS IW with Universal Viewer Version 5.0 and Centricity Universal Viewer Version 6.0 products, GE Healthcare
Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine PDF246KB
· 2015.08.27 Recall for Disposable paper filter for sterilization containers, Stryker Leibinger GmbH & Co. KG
General equipment for medical treatment - cleaning / disinfection / sterilisation PDF181KB
· 2015.08.27 Safety Notice/Update to the IFU for the Siesta i TS machine, DAMECA A/S
Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF61KB
· 2015.08.27 Important Safety Notice for the WATCHMAN Left Atrial Appendage Closure Device with Delivery System and the WATCHMAN Access System, Boston Scientific International S.A.
Non-active implants - cardiac surgery PDF173KB
· 2015.08.27 Corrective action for the ADAC VERTEX Plus, CARDIO, SOLUS or VERTEX V60 (Manual Collimator Exchange system), Philips Healthcare
Radiological technology - equipment for nuclear medical functional and localisation diagnostics PDF276KB
· 2015.08.27 Recall for the Easypump II, B. Braun Melsungen AG
Injections / Infusions / Transfusions / Dialysis - infusion technology PDF67KB
· 2015.08.25 Corrective action regarding Medidrug ALC VB, MEDICHEM Diagnostica GmbH & Co. KG
In-vitro diagnostics - haematological, histological and cytological products PDF2MB
· 2015.08.25 Corrective action for the syngo RT Therapist™ and the Control Console with the Digital Linear Accelerator, Siemens AG
Radiotherapy / Radiation protection - radiotherapy treatment planning systems PDF48KB
· 2015.08.25 Corrective action for the ADVIA Centaur® XPT System, Siemens Healthcare Diagnostics
In-vitro diagnostics - equipment / products for clinical chemistry PDF112KB
· 2015.08.25 Corrective action for the Lightspeed CT scanner or Discovery ST and Discovery LS PET CT Scanner, GE Healthcare
Radiological technology - CT scanners PDF111KB
· 2015.08.25 Corrective action for the Puritan Bennett™ 980 Series Ventilator System (Universal and Neonatal Models), Covidien LLC
Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF110KB
· 2015.08.25 Urgent Safety Notice for certain Medrad® Mark 7 Arterion® Injection Systems, Bayer Medical Care Inc.
Injections / Infusions / Transfusions / Dialysis - infusion technology PDF65KB
· 2015.08.24 Safety Notice for the Cios Alpha mobile C-arm x-ray System, Siemens Healthcare
Radiological technology - mobile radiological diagnostic facilities PDF2MB
· 2015.08.24 Corrective action for the MEDUMAT Transport ventilator, WEINMANN Emergency Medical Technology GmbH + Co. KG
Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF118KB
· 2015.08.24 Recall of Compoflex® and Composelect® bloodbag systems, Fresenius Kabi
Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells PDF28KB
· 2015.08.24 Recall for the Link® Endo-Modell® Tibial Plateau Sets” and “Link® Endo-Modell® Replacement Sets, WALDEMAR LINK GmbH & Co. KG
Non-active implants - bone surgery PDF124KB
· 2015.08.24 Safety Notice for the ACUSON SC2000 ultrasound systems, Siemens Medical Solutions USA, Inc.
Ultrasonics - ultrasonic diagnostic equipment PDF3MB
· 2015.08.24 Urgent Safety Notice/Update for the Edwards Commander Delivery System, Edwards Lifesciences LLC
Injections / Infusions / Transfusions / Dialysis – catheters PDF69KB
· 2015.08.20 Corrective action for the product B·R·A·H·M·S Calcitonin RIA, B•R•A•H•M•S GmbH
In-vitro diagnostics - immunological products PDF129KB
· 2015.08.20 Further Information concerning the Target Coils, Stryker Neurovascular
Non-active implants - special implants PDF29KB
· 2015.08.20 Corrective action for the Supplementary Reagents for CFT (Sheep Blood), Siemens Healthcare Diagnostics
In-vitro diagnostics - microbiological products PDF629KB
· 2015.08.20 Further Safety Information regarding Dade® Actin® Activated Cephaloplastin Reagent, Siemens Healthcare Diagnostics
In-vitro diagnostics - haematological, histological and cytological products PDF30KB
· 2015.08.20 Corrective action for the Philips Ingenuity TF PET/MR system, Philips Healthcare
Electromedical fields - equipment for MR tomography PDF178KB
· 2015.08.19 Corrective action for the Allura Xper Systems (Monitor Ceiling Suspension), Philips Healthcare
Radiological technology - radiological equipment for vascular diagnostics PDF334KB
· 2015.08.19 Corrective action for the Leica ASP6025 Tissue Processor, Leica Biosystems Nussloch GmbH
In-vitro diagnostics - instruments, apparatuses and systems PDF1MB
· 2015.08.19 Corrective action for the 5.5-50 mm Continuous Radius Rods, X-spine Systems, Inc.
Medical instruments for use in humans - bone surgery PDF1MB
· 2015.08.19 Recall for the Wrap for Medullary Nails, Synthes GmbH
General equipment for medical treatment - cleaning / disinfection / sterilisation PDF2MB
· 2015.08.18 Recall for the product "Proximal Lighting Insert", Richard Wolf GmbH
Optics / Precision engineering – endoscopes PDF4MB
· 2015.08.18 Corrective action for the MicroScan LabPro Information Manager System, Beckman Coulter
In-vitro diagnostics - microbiological products PDF254KB
· 2015.08.18 Safety Notice for the Digital Linear Accelerators/Update for the syngo RT Therapist™ software and the Control Console software, Siemens AG
Radiotherapy / Radiation protection - radiotherapy treatment planning systems PDF26KB
· 2015.08.18 Corrective action for the DRX Evolution Systems w/Premium and Full Featured Wall stands, Carestream Health, Inc.
Radiological technology - stationary radiological equipment PDF33KB
· 2015.08.18 Urgent Safety Notice for the DigitalDiagnost 4.1/4.1.1, Philips Medical Systems
Radiological technology - stationary radiological equipment PDF20KB
· 2015.08.18 Urgent Safety Notice for the wheelchair Quickie Jive UP, Sunrise Medical
Orthopaedic / Rehabilitation technology - mobility aids PDF403KB
· 2015.08.17 Corrective action for the ADVIA Centaur Systems Folate Ascorbic Acid/Ascorbic Acid Diluent, Siemens Healthcare Diagnostics
In-vitro diagnostics - equipment / products for clinical chemistry PDF27KB
· 2015.08.17 Corrective action for Dimension Vista® Creatinine (CREA), Siemens Healthcare Diagnostics
In-vitro diagnostics - equipment / products for clinical chemistry PDF42KB
· 2015.08.17 Recall NEFA FS, DiaSys Diagnostic Systems GmbH
In-vitro diagnostics - equipment / products for clinical chemistry PDF2MB
· 2015.08.17 De Puy Synthes: Recall for the Socket hexagonal, Ø 4.0/11.0 mm, cannulated
Medical instruments for use in humans - bone surgery PDF3MB
· 2015.08.17 Recall for the Insufflation hose, silicone, XION GmbH
Optics / Precision engineering – endoscopes PDF306KB
· 2015.08.17 Recall for the VEPTR® Caudal Rib Supports (Rib-to-Rib Construct only), Synthes GmbH
Non-active implants - bone surgery PDF4MB
· 2015.08.17 Recall for the product Hyperventilation mask, Yuyao Shengchang Medical Instrument Factory
Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF8KB
· 2015.08.17 Corrective action for the Sapphire Infusion Pump, Q Core Medical
Injections / Infusions / Transfusions / Dialysis - infusion technology PDF120KB
· 2015.08.13 Corrective action for the Pioneer® Plus Catheter, Volcano Corporation
Ultrasonics - ultrasonic diagnostic equipment PDF87KB
· 2015.08.13 Corrective action for the Access Thyroglobulin Reagent Kit, Beckman Coulter
In-vitro diagnostics - immunological products PDF31KB
· 2015.08.13 Corrective action for the cobas® 6800 / 8800 systems, Roche Diagnostics
In-vitro diagnostics - equipment / products for clinical chemistry PDF99KB
· 2015.08.13 Urgent Safety Notice for the TraumaDiagnost systems, Philips Medical Systems
Radiological technology - stationary radiological equipment PDF20KB
· 2015.08.13 Recall for AngioJet® Thrombectomy Sets, Boston Scientific International S.A.
Injections / Infusions / Transfusions / Dialysis – catheters PDF161KB
· 2015.08.13 Corrective action for the TRIGEN 8/7 mm x 24 cm Humeral Nail, Smith & Nephew Inc.
Non-active implants - bone surgery PDF79KB
· 2015.08.13 Recall for the product HQD Flow Probe, Transonic Systems, Inc.
Surgical equipment/ Anaesthesia - surgical equipment PDF1MB
· 2015.08.13 Updated Safety Information concerning NDI Disposable Reflective Marker Sphere, Northern Digital Inc.
Medical instruments for use in humans - cardiac/thorax surgery PDF372KB
· 2015.08.11 Corrective action for the ExacTrac 6.0 Patient Positioning System, Brainlab AG
Radiotherapy / Radiation protection - radiotherapy treatment planning systems PDF327KB
· 2015.08.11 Recall for the E-tegra Stent Graft System, JOTEC GmbH
Non-active implants - special implants PDF537KB
· 2015.08.11 Recall for the ARROW® International PICC Kits with Peel-Away Sheath Component, Arrow International, Inc.
Injections / Infusions / Transfusions / Dialysis – catheters PDF188KB
· 2015.08.11 Important Safety Information for the Intrauterine Contraceptives Mirena and Nova T 380, Bayer Healthcare
Contraception - intrauterine device PDF3MB
· 2015.08.11 Corrective action for the Philips G60 patient monitor, Philips Goldway (Shenzhen) Industrial Inc.
Medical electronics / Electromedical devices – electrodiagnostics PDF167KB
· 2015.08.11 Recall for the Mucolexx / Mucolytic Agent, Richard Allan Scientific
In-vitro diagnostics - haematological, histological and cytological products PDF534KB
· 2015.08.10 Corrective action concerning the M6 service head, Ondal Medical Systems GmbH
Surgical equipment/ Anaesthesia - surgical equipment PDF5MB
· 2015.08.10 Corrective action for the rollator TOPRO Troja 2G, TOPRO Industri AS
Orthopaedic / Rehabilitation technology - daily living aids PDF770KB
· 2015.08.10 Recall for the EOPA® Arterial Cannula, Medtronic
Injections / Infusions / Transfusions / Dialysis - syringes and cannulas PDF95KB
· 2015.08.10 Corrective action for the RHK femoral components, Biomet UK Ltd.
Non-active implants - bone surgery PDF2MB
· 2015.08.10 Corrective action for the ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET, Tosoh Corporation
In-vitro diagnostics - equipment / products for clinical chemistry PDF221KB
· 2015.08.04 Corrective action for the iChemVELOCITY systems using iChemVELOCITY Urine Chemistry Strips, Beckman Coulter, Inc.
In-vitro diagnostics - equipment / products for clinical chemistry PDF1MB
· 2015.08.04 Recall of MANI Trocar Kit, MANI, Inc.
ophthalmological technology - equipment for ophthalmological therapeutics PDF22KB
· 2015.08.04 Recall for the product Oxoid MacConkey Agar No. 3, Thermo Fisher Scientific
In-vitro diagnostics - microbiological products PDF279KB
· 2015.08.04 Urgent Safety Notice for the product BD BBL™ CHROMagar™ MRSA II, Becton Dickinson
In-vitro diagnostics - microbiological products PDF58KB
· 2015.08.04 Corrective action for the Fluitest CREA PAP and for all products based on the “Trinder Reaction”, Analyticon Biotechnologies AG
In-vitro diagnostics - equipment / products for clinical chemistry PDF40KB
· 2015.08.04 Corrective action for the adjustable positioning elements, MAQUET GmbH
Surgical equipment/ Anaesthesia - surgical equipment PDF884KB
· 2015.08.03 Urgent Safety Notice for the BD CD56 PE-Cy™7 reagent, Becton, Dickinson & Company, BD Biosciences
In-vitro diagnostics - immunological products PDF50KB
· 2015.08.03 Urgent Safety Notice for the Samsung LABGEOPT Lipid Test 5S and LABGEOPT Lipid Test 5, Samsung Electronics
In-vitro diagnostics - equipment / products for clinical chemistry PDF153KB
· 2015.08.03 Urgent Safety Notice for the DFM Transcatheter Aortic Valve System, Direct Flow Medical®
Non-active implants - cardiac surgery PDF223KB
· 2015.08.03 Corrective action for the IBC Aortic Punch products, International Biophysics Corporation
Medical instruments for use in humans - vascular surgery PDF50KB
· 2015.08.03 Safety Information for the MicroSil IF and MicroSil IFT intraocular lenses, HumanOptics AG
Non-active implants - special implants PDF117KB
· 2015.08.03 Corrective action for the m2000sp E-series Instrument and m24sp Instrument,
In-vitro diagnostics - instruments, apparatuses and systems PDF33KB
· 2015.08.03 Urgent Safety Notice for the Parechovirus r-gene® product, bioMérieux SA
In-vitro diagnostics - immunological products PDF89KB
· 2015.08.03 Urgent Safety Notice for the TurnPike Spiral and TurnPike Gold catheters, Vascular Solutions, Inc.
Injections / Infusions / Transfusions / Dialysis – catheters PDF79KB