Німеччина
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Lot recall of LaserEdge Knives, Valeant Pharmaceuticals International Inc. / Bausch & Lomb
ophthalmological technology - equipment for ophthalmological therapeutics
Recall of Lotus valve system, Boston Scientific International S.A.
Non-active implants - cardiac surgery
Recall of ball electrode, inomed Medizintechnik GmbH
Medical electronics / Electromedical devices - electrotherapy
Lot recall of Check-Flo hemostasis assembly / Flexor radial access sets / TriForce peripheral crossing set / Check-Flo introducer (Hausdorf-lock atrial), Cook Medical Europe
Injections / Infusions / Transfusions / Dialysis - catheters
Batch recall of custom procedure packs containing Medtronic / Covidien Devon Light Gloves, Pennine
Surgical equipment/ Anaesthesia - surgical equipment
Urgent field safety notice for evo and eco c, Schwarzer Cardiotek GmbH
Medical electronics / Electromedical devices - electrodiagnostics
Urgent field safety notice for LIFEPAK 15 monitor / defibrillator, PHYSIO-CONTROL Inc.
Medical electronics / Electromedical devices - electrotherapy
Urgent field safety notice for modular femoral heads (CoCr) / Protasul S30 femoral heads / Metasul heads, Zimmer Biomet / Zimmer GmbH
Non-active implants - bone surgery
Recall of syringe 100 ml with catheter tip and Luer adapter, Fuhrmann GmbH
Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Recall of Stoma support ring KR-XX, Koring AG
Orthopaedic / Rehabilitation technology - care of natural and artificial body orifices
Urgent field safety notice for ProteusPLUS and ProteusONE, IBA
Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Lot recall of Bone Wax Stick, B. Braun Surgical S.A.
Dressings / Pads - ointments and gels
Urgent field safety notice for Helical infusion catheter and steerable Morph universal guide catheter, BioCardia Inc.
Injections / Infusions / Transfusions / Dialysis - catheters
Lot recall of STADA diagnostic H.pylori self-tests, MEXACARE GmbH
In-vitro diagnostics - immunological products
Urgent field safety notice for Unyvero BCU blood culture (Propionibacterium acnes), Curetis GmbH
In-vitro diagnostics - instruments, apparatuses and systems
Urgent field safety notice for RFX/SFX / Legacy / Precision 500D, GE Healthcare
Radiological technology - stationary radiological equipment
Recall of radial head prosthesis MoPyC, Tornier
Non-active implants - bone surgery
Urgent field safety notice for Aiming Arm for DFN / combined / for PAD, DePuy Synthes / Synthes GmbH
Medical instruments for use in humans - bone surgery
Urgent field safety notice for Offset Cup Impactor Universal, Brainlab AG
Surgical equipment/ Anaesthesia - surgical equipment
Recall of FlexTherm Heater Cooler Device, Sorin / LivaNova
Surgical equipment/ Anaesthesia - surgical equipment
Lot recall of Monosyn undyed 7/0 (0,5) 45 cm DSMP7, B. Braun Surgical S.A.
Dressings / Pads - surgical sutures, vascular loops etc.
Urgent field safety notice for Oncentra External Beam Oncentra Brachy, Elekta AB / Nucletron B.V.
Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Lot recall of TIPSS-200 Transjugular Intrahepatic Portosystemic Shunt Procedure Pack, William Cook Europe Aps / Cook Medical Europe
Non-active implants - special implants
Lot recall of NuPortCT and C-PortCT port catheter systems containing F9.6 silicone catheters, PHS Medical GmbH
Non-active implants - special implants
Lot recall of MobiCath Bi-Directional Guiding Sheath, Greatbatch Medical / MPS Medical Product Service GmbH
Injections / Infusions / Transfusions / Dialysis - catheters
Lot recall of various spine instruments, DePuy Synthes / Synthes GmbH
Medical instruments for use in humans - bone surgery
Lot recall of Devon™ Light Gloves, Medtronic GmbH
Surgical equipment/ Anaesthesia - surgical equipment
Recall of ProcedurePak trays containing Syringe 100 ml 3parts Cath. tip Conc. W/LS Adapter (BD Plastipak Syringe, Catheter tip with Luer slip adaptor), Mölnlycke Health Care
Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Lot recall of Safil Violet 2/0 (3) 12x45 cm, B. Braun Surgical S.A.
Dressings / Pads - surgical sutures, vascular loops etc.
Lot recall of Menicon soft 72, Menicon Co. Ltd.
ophthalmological technology - contact lenses
Lot recall of sterile disposable feeding bottles / sterile disposable breast milk collector sets, Beldico S.A.
General equipment for medical treatment - medico-mechanical devices
Lot recall of 1.5 mm Hydro Valvulotome, LeMaitre Vascular GmbH
Medical instruments for use in humans - cardiac/thorax surgery
Urgent field safety notice for dilator and sheath length 460 mm / d 1,7 mm (F5) / with haemostatic valve, Ecomedis Medizintechnik GmbH
Medical instruments for use in humans - gynaecology
Urgent field safety notice for ExacTrac Vero 3.5.0 - 3.5.3, Brainlab AG
Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Urgent field safety notice for ceiling unit CU 5001/3 and CU 3-21/23, MÖLLER-WEDEL GmbH & Co. KG
Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Urgent field safety notice for VERSAJET II Hydrosurgery System Console, Smith & Nephew Medical Ltd.
Surgical equipment/ Anaesthesia - surgical equipment
Urgent field safety notice for MetaToe ReadyToUse Kit, Merete GmbH
Non-active implants - bone surgery
Urgent field safety notice for iChemVELOCITY automated urine chemistry systems, Beckman Coulter / Iris International
In-vitro diagnostics - equipment / products for clinical chemistry
Urgent field safety notice for Kleihauer Kit, IMMUCOR Medizinische Diagnostik GmbH
In-vitro diagnostics - haematological, histological and cytological products
Urgent field safety notice for Elecsys TSH / PTH, Roche Diagnostics
In-vitro diagnostics - immunological products
Lot recall of Super Arrow-Flex Percutaneous Sheath Introducer Set, Arrow International Inc. / Teleflex Medical
Injections / Infusions / Transfusions / Dialysis - catheters
Urgent field safety notice for MEDUCORE Easy battery packs, WEINMANN Emergency Medical Technology GmbH + Co. KG
Medical electronics / Electromedical devices - electrotherapy
Recall of Plastipak Syringe, Catheter tip with Luer slip adapter 100 ml, Becton Dickinson (BD) / Lohmann & Rauscher GmbH & Co. KG
Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Urgent field safety notice for XRCISE STRESS ECHO MED, ERGO-FIT GmbH & Co. KG / cardiowise GmbH
Medical electronics / Electromedical devices - functional diagnostics by way of gas exchange and exercise
Lot recall of Valleylab Laparoscopic Handset Four-Function, Medtronic
Medical electronics / Electromedical devices - electrotherapy
Urgent field safety notice for ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK, PENTAX Europe GmbH
Optics / Precision engineering - endoscopes
Lot recall of clip applicator, MTW-Endoskopie W. Haag KG
Medical instruments for use in humans - general instruments
Lot recall of Accu-Cut Saw Blade AO Drive, Zimmer Biomet UK Ltd.
Surgical equipment/ Anaesthesia - surgical equipment
Recall of HeartMate PHP Catheter, Abbott
Active implantable medical devices - artificial hearts
Batch recall of Intraocular lenses CT ASPHINA 409MP, Carl Zeiss Meditec AG
Non-active implants - special implants
Batch recall of LEGION HINGE KNEE FEMORAL ASSEMBLY, Smith & Nephew Inc.
Non-active implants - bone surgery
Recall of Li-Ion Battery used with Maquet CARDIOSAVE Hybrid IABP / Rescue IABP, Maquet Getinge Group
Surgical equipment/ Anaesthesia - surgical equipment
Recall of StarClose SE Vascular Closure System, Abbott Vascular Deutschland GmbH
Non-active implants - special implants
Urgent field safety notice for Kiwi Omni Cup, Clinical Innovations
Medical instruments for use in humans - gynaecology
Urgent field safety notice for Atrium Thoracic Catheters, Maquet Getinge Group
Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Urgent field safety notice for Artis systems with software versions VC14 / VC21 / VD10 / VD11 und VE10, Siemens Healthcare GmbH
Radiological technology - radiological equipment for vascular diagnostics
Urgent field safety notice for Artis zee systems with specific delivery losts of the A100Plus generator in combination with 2-focus Megalix Cat Plus tube units, Siemens Healthcare GmbH
Radiological technology - radiological equipment for vascular diagnostics
Urgent field safety notice for digital linear accelerators of type PRIMUS / MEVATRON, Siemens Healthcare GmbH
Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Urgent field safety notice for digital linear accelerators of type ARTISTE / ONCOR / PRIMUS, Siemens Healthcare GmbH
Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Urgent field safety notice for Strata II / Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]), Medtronic
Non-active implants - special implants
Urgent field safety notice for trailer kit 24598 and 24875 in trikes without rear suspension Trix / Kettwiesel / Trets Reh, Hase Bikes
Orthopaedic / Rehabilitation technology - mobility aids
Urgent field safety notice for ETEST XM256 (Cefuroxime), bioMérieux SA
In-vitro diagnostics - microbiological products
Lot recall of Xpert BCR-ABL, Cepheid
In-vitro diagnostics - immunological products
Recall of C2 CryoBalloon Controller Cap, C2 Therapeutics Inc.
Surgical equipment/ Anaesthesia - surgical equipment
Urgent field safety notice for Discovery MR450 narrow bore 1.5T MRI, GE Healthcare
Electromedical fields - equipment for MR tomography
Urgent field safety notice for RayStation 2.5 / 3.0 / 3.5 / 4.0 / 4.5 / 4.7 / 5.0 / 4.3 (InverseArc), RaySearch Laboratories AB
Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Urgent field safety notice for 3M™ Tegaderm PICC CVC Securement Device + CHG I.V. Securement Dressing, 3M Deutschland GmbH
Dressings / Pads - dressings
Lot recall of LASEREDGE 2.0 mm x 2.0 mm Trapezoid Angled 6/Box, Valeant Pharmaceuticals International Inc.
ophthalmological technology - equipment for ophthalmological therapeutics
Urgent field safety notice for RayStation 4.5 / 4.7 / 5 / 6, RaySearch Laboratories AB
Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Lot recall of LEGION CRUCIATE RETAINING NARROW Femoral Component SZ 5 RT, Smith & Nephew Inc.
Non-active implants - bone surgery
Lot recall of FOCUS FORCE intraocular lenses, Anadolu Tip Teknolojileri A.S.
Non-active implants - special implants