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Urgent field safety notice for SOMATOM Definition AS and SOMATOM Definition Flash, Siemens Healthcare GmbH
Radiological technology - CT scanners
Urgent field safety notice for SOMATOM Definition AS and SOMATOM Definition Flash, Siemens Healthcare GmbH
Radiological technology - CT scanners
Urgent field safety notice for Femoral and Tibial Cutting Block Adapter, Brainlab AG
Radiological technology - navigation systems
Lot recall of QMS Everolimus Immunoassay, Thermo Fisher Scientific / Microgenics Corporation
In-vitro diagnostics - equipment / products for clinical chemistry
Lot recall of Cholinesterase FS, DiaSys Diagnostic Systems GmbH
In-vitro diagnostics - equipment / products for clinical chemistry
Urgent field safety notice for RayStation 5, RaySearch Laboratories AB
Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Urgent field safety notice for Innova 2100IQ / 3100 / 3100IQ / 4100 / 4100IQ, GE Healthcare
Radiological technology - radiological equipment for vascular diagnostics
Urgent field safety notice for IACS SW Version VG5.0, Draeger Medical Systems Inc.
Medical electronics / Electromedical devices - electrodiagnostics
Urgent field safety notice for Biosen Glucose / Lactate Consumables, EKF-diagnostic GmbH
In-vitro diagnostics - equipment / products for clinical chemistry
Lot recall of LASEREDGE 1.5 mm x 1.7 mm Trapezoid Angled 6 / Box, Bausch+Lomb OPS B.V. / Valeant Pharmaceuticals International Inc.
ophthalmological technology - equipment for ophthalmological therapeutics
Urgent field safety notice for boso TM-2430 PC2, Bosch + Sohn GmbH u. Co. KG
Medical electronics / Electromedical devices - electronic blood pressure monitor
Lot recall of DRI Salicylate Serum Tox Assay, Thermo Fisher Scientific / Microgenics GmbH
In-vitro diagnostics - equipment / products for clinical chemistry
Urgent field safety notice for GLU / LAC / UREA (BUN) Cassette, Roche Diagnostics GmbH
In-vitro diagnostics - equipment / products for clinical chemistry
Urgent field safety notice for Prometra programmable pump (REF 91827), Flowonix Medical Inc.
Active implantable medical devices - drug pumps
Urgent field safety notice for central axis system, S.I.M.E.O.N.
Surgical equipment/ Anaesthesia - surgical equipment
Urgent field safety notice for CPX4 Medium Height Breast Tissue Expander 650 cc, Mentor
Non-active implants - special implants
Urgent field safety notice for Brilliance 64 and Ingenuity CT / Core / Core128, Philips Healthcare
Radiological technology - CT scanners
Urgent field safety notice for Chemistry Calibrator, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics - equipment / products for clinical chemistry
Lot recall of PATHFAST Myoglobin, Mitsubishi Chemical Europe GmbH
In-vitro diagnostics - immunological products
Lot recall of NADAL RSV rapid test, nal von minden GmbH
In-vitro diagnostics - microbiological products
Urgent field safety notice for Heater Unit HU 35 and Heater-Cooler Unit HCU 20 / 30 / 40, Maquet Cardiopulmonary GmbH
Surgical equipment/ Anaesthesia - surgical equipment
Lot recall of SelectiCure L19, 3M Deutschland GmbH
Injections / Infusions / Transfusions / Dialysis - dialysis technology
Urgent field safety notice for FACET WEDGE, DePuy Synthes / Synthes GmbH
Non-active implants - bone surgery
Recall of IBS-TITAN TLIF II, Peter Brehm GmbH
Non-active implants - bone surgery
Urgent field safey notice for Dialog+ Dialysis Machines with Software 8.2A, B. Braun
Injections / Infusions / Transfusions / Dialysis - dialysis technology
Batch recall of ORG 908MX Anti Mumps Virus IgM, ORGENTEC Diagnostika GmbH
In-vitro diagnostics - microbiological products
Recall of Pipeline Embolization Device (Pipeline Classic) / Alligator Retrieval Device / Xcelerator Hydrophilic Guidewire / UltraFlow HPC Flow Directed Microcatheter / Marathon Flow Directed Microcatheter, Medtronic
Non-active implants - special implants
Urgent field safety notice for Devon Light Glove, Medtronic / Covidien
Surgical equipment/ Anaesthesia - surgical equipment
Urgent field safety notice for Devon Light Glove, Medtronic / Covidien
Surgical equipment/ Anaesthesia - surgical equipment
Urgent field safety notice for ARCHITECT Lactic Acid reagent, Abbott Laboratories
In-vitro diagnostics - equipment / products for clinical chemistry
Urgent field safety notice for Model 37751 Recharger included in Model 37651 Charging System, Medtronic
Active implantable medical devices - biostimulators
Urgent field safety notice for Algovita Spinal Cord Stimulation System, Nuvectra
Active implantable medical devices - biostimulators
Lot recall of Reducer Kit, Neovasc
Non-active implants - special implants
Lot recall of gabControl D-Dimer rapid test (M09DD02), gabmed GmbH
In-vitro diagnostics - haematological, histological and cytological products
Urgent field safety notice for IntelliVue MX40, Philips Healthcare
Medical electronics / Electromedical devices - electrodiagnostics
Batch recall of AV-Set B-R, Fresenius Medical Care
Injections / Infusions / Transfusions / Dialysis - dialysis technology
Urgent field safety notice for Combi Dockable Table Neurosurgery, Siemens Healthcare GmbH
Electromedical fields - equipment for MR tomography
Lot recall of PT Owren’s GHI131-10 SI, MediRox AB
In-vitro diagnostics - haematological, histological and cytological products
Urgent field safety notice for Vitamin D Total, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics - equipment / products for clinical chemistry
Lot recall of Trident Universal Impactor / Positioner, Stryker Orthopaedics
Medical instruments for use in humans - bone surgery
Lot recall of sterile Reaming Rods for SynReam, DePuy Synthes / Synthes GmbH
Medical instruments for use in humans - bone surgery
Recall of Guider Guide Catheter, Stryker Neurovascular
Injections / Infusions / Transfusions / Dialysis - catheters
Lot recall of drill dia. 1.9 mm, lntegra LifeSciences Services (France)
Medical instruments for use in humans - bone surgery
Recall of LAA Occluder, Occlutech International AB
Non-active implants - cardiac surgery
Recall of SONNET Rechargeable Battery Pack Cover Micro Black, MED-EL Elektromedizinische Geräte GmbH
Active implantable medical devices - biostimulators
Lot recall of Pop-On Self-Adhering Male External Catheter, C. R. Bard Inc.
Injections / Infusions / Transfusions / Dialysis - catheters
Urgent field safety notice for Fortify / Fortify Assura / Quadra Assura / Quadra Assura MP / Unify / Unify Assura / Unify Quadra, St. Jude Medical Inc.
Active implantable medical devices - defibrillators
Lot recall of MicroTrak Syphilis TPHA PK, Trinity Biotech Manufacturing Limited
In-vitro diagnostics - microbiological products
Urgent field safety notice for Aptio Automation Modules, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics - equipment / products for clinical chemistry
Urgent field safety notice for surgical tables axis 400-800, Schaerer Medical AG
Surgical equipment/ Anaesthesia - surgical equipment
Lot recall of MUTARS filia prox. femur incl. safety screw, implantcast GmbH
Non-active implants - bone surgery
Batch recall of Innex Knee System / Tibial Alignment Guide Proximal, Zimmer Biomet / Zimmer GmbH
Medical instruments for use in humans - bone surgery
Urgent field safety notice for Flashlite Magna 4.0, DenMat / American Dental Systems GmbH
Dental products - equipment
Urgent field safety notice for TCM5 FLEX and TCM5 BASIC, Radiometer
Medical electronics / Electromedical devices - electrodiagnostics
Urgent field safety notice for Ultrasonic Endoscope EG-530UT2 / EG-530UR2, FUJIFILM / Aquilant Endoscopy
Optics / Precision engineering - endoscopes
Urgent field safety notice for BLOTrix 3.4, BioSciTec GmbH
In-vitro diagnostics - equipment / products for clinical chemistry
Urgent field safety notice for MicroTrak Syphilis TPHA PK, Trinity Biotech
In-vitro diagnostics - microbiological products
Urgent field safety notice for Evidence lnvestigator EV3602, Randox Laboratories Ltd.
Medical data processing (software) - others
Urgent field safety notice for proGAV 2.0, Christoph Miethke GmbH & Co. KG
Non-active implants - special implants
Lot recall of EZ-Tip, Research Instruments Limited
In vitro fertilization - others
Urgent field safety notice for Synapse PACS software, FUJIFILM Medical Systems USA Inc.
Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Recall of PFO-Occluders, Acoredis GmbH
Non-active implants - cardiac surgery
Recall and after-care recommendation for WATCHMAN FLX Left Atrial Appendage (LAAC) Closure Device, Boston Scientific International S.A.
Non-active implants - cardiac surgery
Lot recall of NexGen LPS Femoral, Zimmer Biomet / Zimmer GmbH
Non-active implants - bone surgery
Urgent field safey notice for FindrWIRZ, SentreHEART Inc.
Injections / Infusions / Transfusions / Dialysis - catheters
Urgent field safety notice for ProcedurePak kits and trays, Mölnlycke Health Care
Dressings / Pads - others
Urgent field safety notice for Life-Point AEDs, METsis Medikal Ltd. Sti.
Medical electronics / Electromedical devices - electrotherapy
Urgent field safety notice for Spectra-System / ScrewPlant / ScrewPlus / ScrewIndirect / ScrewDirect / ScrewRedirect / GoDirect / Legacy / RePlant / RePlus / ReActive / SwishPlant / SwishPlus / SwishActive / InterActive Systems, Implant Direct Sybron Manufacturing LLC / Emergo Europe
Dental products - dental implants
Urgent field safety notice for MAC 600 / 800 / 1200 / 1600 / 2000 / 3500 / 5000 / 5500 / 5500 HD, GE Healthcare
Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Urgent field safety notice for iPlan RT Radiation Treatment Planning Software, Brainlab AG
Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Urgent field safety notice for Dimension Vista System Chemistry 1 Calibrator, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics - equipment / products for clinical chemistry