Людям із порушенням зору 
In English Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.11.2016 – 30.11.2016
Опубліковано 06.12.2016 о 00:00
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Lot / batch recall of Radial Fiber, advanced fiber tools GmbH
Medical instruments for use in humans – vascular surgery
Lot recall of Semislip guidewires, Urotech GmbH
Injections / Infusions / Transfusions / Dialysis – catheters
Lot recall of diverse sterile medical products, Wright Medical UK Ltd.
Non-active implants – bone surgery
Lot recall of Bowl with 2 sections, STS Medical Group S.à.r.l. / Sengewald / MSP Schmeiser GmbH
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for DiagnostikSuite, Zimmer MedizinSysteme GmbH
Medical electronics / Electromedical devices – pulmonary function diagnostics
Lot recall of catheter connection / disconnection sets, Bionic Medizintechnik GmbH
Injections / Infusions / Transfusions / Dialysis – catheters
Lot / batch recall of PEG-Set with fixation / without fixation / primary, Fuhrmann GmbH
Dressings / Pads – dressings
Urgent field safey notice for Accu-Chek Connect diabetes management app version 1.2.0, Roche Diabetes Care
Injections / Infusions / Transfusions / Dialysis – infusion technology
Batch recall of Cellfina System Prep Pack CP1, Merz Pharmaceuticals GmbH
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for Avance CS2 / Avance / Amingo, GE Healthcare
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Urgent field safety notice for fabian HFO / evolution, ACUTRONIC Medical Systems AG
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Urgent field safety notice for Mobile Digital X-Ray GM60A, Samsung Electronics
Radiological technology – mobile radiological diagnostic facilities
Lot recall of Drill 1 and 2 / Twist Drill PRO / Starter Set, Straumann GmbH
Medical instruments for use in humans – bone surgery
Batch recall of D-Dimer Rapid Test D-DIMK20, Diagnostik Nord GmbH
In-vitro diagnostics – haematological, histological and cytological products
Urgent field safety notice for hemodialysis machines Formula / 2000 / Plus / 2000 Plus / Therapy and Domus, Medtronic GmbH
Injections / Infusions / Transfusions / Dialysis – dialysis technology
Urgent Field Safey Notice for RayStation 4.0 / 4.5 / 4.7 and 5.0, RaySearch Laboratories
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Recall of Acuvance®2 Safety Catheter, Smiths Medical ASD
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Lot recall of WECK Visistat 35W, Teleflex Medical
Medical instruments for use in humans – general instruments
Recall of CELON ELITE ESG-200 / Model Number WA90001A, OLYMPUS Deutschland GmbH
Medical electronics / Electromedical devices – electrotherapy
Lot recall of GREATBATCH Medical Offset Reamer Handle (00-7804-080-00), Zimmer Biomet
Medical instruments for use in humans – bone surgery
Lot / batch recall of Bridge Occlusion Ballon, Spectranetics Corporation
Injections / Infusions / Transfusions / Dialysis – catheters
Lot / batch recall of Turbo Elite atherectomy catheter / ELCA coronary atherectomy catheter, Spectranetics Corporation
Injections / Infusions / Transfusions / Dialysis – catheters
Recall of SONNET Mini Battery Pack Cable, MED-EL Elektromedizinische Geräte GmbH
Active implantable medical devices – biostimulators
Lot recall of ART-1023 Quinn’s Advantage Medium with Hepes, CooperSurgical Inc. / ORIGIO
Physical therapy – others
Batch recall of Reflection Dead Blow Mallet, Smith & Nephew Inc.
Medical instruments for use in humans – bone surgery
Urgent field safety notice for Elekta AB / IMPAC Medical Systems Inc.
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Urgent field safety notice for IMMULITE 2000 / XPi, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Double Balloon Catheter / Isofuse Isolation Aspiration Catheter, Delcath Systems Inc.
Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures
Lot recall of E.MOTION PS PRO MENISCAL COMPONENT F3L 20 mm, Aesculap AG
Non-active implants – bone surgery
Urgent field safety notice for PEG 20FR Tube, AbbVie
Injections / Infusions / Transfusions / Dialysis – probes
Urgent field safety notice for FlexLab power cord, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
Recall of Modular Neck Hip Prostheses of Modular SMF and Modular REDAPT Revision Femoral Hip Systems, Smith & Nephew Inc.
Non-active implants – bone surgery
Urgent field safety notice for S5 / C5 Perfusion System, LivaNova / Sorin Group Deutschland GmbH
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for SynchroMed II Implantable Drug Infusion Pump, Medtronic
Active implantable medical devices – drug pumps
Lot recall of K-Wire(s) sterile packaging, Stryker Orthopaedics / Stryker Trauma GmbH
Non-active implants – bone surgery
Lot recall of SynReam / Flexible shaft, DePuy Synthes / Synthes GmbH
Medical instruments for use in humans – bone surgery
Urgent field safety notice for Sara Combilizer, ArjoHuntleigh / Getinge Group
General equipment for medical treatment – ward equipment and equipment for emergency medical services
Lot recall of LASEREDGE 1.5 mm x 1.7 mm Trapezoid Angled 6 / Box, Valeant Pharmaceuticals International Inc. / Bausch + Lomb OPS B.V.
ophthalmological technology – equipment for ophthalmological therapeutics
Lot recall of ARROW OnControl, Teleflex Medical
Medical instruments for use in humans – bone surgery
Urgent field safety notice for Brilliance iCT / iCT SP / Big Bore / 64 / 40 / 16 / 6 / 10 / 16P and Ingenuity CT / Core / Core128, Philips Healthcare
Radiological technology – CT scanners
Lot / batch recall of NEURO FLAPFIXKIT, KLS Martin Group / Gebrüder Martin GmbH & Co. KG
Non-active implants – bone surgery
EasySept Hydro Plus Cleaning & disinfecting solution, Bausch & Lomb Incorporated / Valeant Pharmaceuticals International Inc.
ophthalmological technology – contact lenses
Urgent field safety notice for NIM Standard / Contact Reinforced EMG Endotracheal Tubes, Medtronic
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Lot recall of Delivery Sheath Adelante Breezeway 8F & 10F / ARRIVE Braided Transseptal Sheath, Oscor Inc. / Medtronic
Injections / Infusions / Transfusions / Dialysis – catheters
Lot recall of Homocystein FS, DiaSys Diagnostic Systems GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
Batch recall of balanSys UNI convex PE inlay x/5, Mathys AG Bettlach
Non-active implants – bone surgery
Lot recall of Galeo Pro Coronary Guidewire, Concert Medical LLC
Injections / Infusions / Transfusions / Dialysis – catheters
Urgent field safety notice for Equinoxe, Exactech Ltd. / UK
Non-active implants – bone surgery
Urgent field safety notice for Devon Light Glove, ArcRoyal
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for Abdominal Aortic & Junctional Tourniquet (AAJT), Compression Works LLC
General equipment for medical treatment – medico-mechanical devices
Urgent field safety notice for automated external defibrillators cardiolife AED-2100K, NIHON KOHDEN EUROPE GmbH
Medical electronics / Electromedical devices – electrotherapy
Urgent field safety notice for lntact-PTH (Parathyroid Hormone) ELISA Kit, Biomerica / MDSS GmbH
In-vitro diagnostics – immunological products
Lot recall of D-Dimer Rapid Tests, Dutch Diagnostics B.V.
In-vitro diagnostics – haematological, histological and cytological products
Lot recall of Proline D-Dimer Pro rapid test (IVD), SuZhou Sensogen Biotech Co. Ltd. / Alltest / Promeditech GmbH
In-vitro diagnostics – haematological, histological and cytological products
Urgent field safety notice for PlGF PLUS KRYPTOR QC, BRAHMS GmbH
In-vitro diagnostics – immunological products
Urgent field safety notice for Endotracheal Tube with Murphy eye size I.D. 7,5 mm and ETT Set with cuffed Murphy ETT ID 7.5 mm, W. Droh GmbH
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Urgent field safety notice for Tina-quant HbA1c Gen.2, Roche
In-vitro diagnostics – equipment / products for clinical chemistry
Lot recall of MicroTrak CMV HA 2000, Trinity Biotech
In-vitro diagnostics – microbiological products
Lot recall of Universal Electrosurgical Pad, 3M Deutschland GmbH
Medical electronics / Electromedical devices – electrotherapy
Lot recall of LOTUS Edge Valve System, Boston Scientific International S.A.
Non-active implants – cardiac surgery
Lot recall of Covidien Clearify Visualization System, Medtronic
Optics / Precision engineering – endoscopes
Urgent field safety notice for AXIOM Artis, Siemens Healthcare GmbH
Radiological technology – radiological equipment for vascular diagnostics
Urgent field safety notice for Artis Q, Siemens Healthcare GmbH
Radiological technology – radiological equipment for vascular diagnostics
Urgent field safety notice for Artis zee, Siemens Healthcare GmbH
Radiological technology – radiological equipment for vascular diagnostics
Urgent field safety notice for BIOLOX delta, Corin Limited
Non-active implants – bone surgery
Urgent field safety notice for ProcedurePak trays containing Light Handle Cover (Devon Light Glove), Mölnlycke Health Care
Surgical equipment/ Anaesthesia – surgical equipment
Recall of Trocar Catheters, Maquet / Getinge
Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Urgent field safety notice for Access Ostase Calibrator Kit and Access Ostase QC Kit, Beckman Coulter
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Monaco, Elekta AB / IMPAC Medical Systems Inc.
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Urgent field safety notice for QuikRead go (instrument) with software 7.1.10, Orion Diagnostica Oy
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Nanostim Leadless Cardiac Pacemaker (LCP) / model number S1DLCP, St. Jude Medical
Active implantable medical devices – cardiac pacemakers
Urgent field safety notice for Parathyroid hormone intact ELISA, IBL International GmbH
In-vitro diagnostics – immunological products
Urgent field safety notice for ADVIA Centaur / XP / XPT / CP, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – immunological products
Urgent field safety notice for Rebalance Talar, Zimmer Biomet / Biomet UK Ltd.
Medical instruments for use in humans – bone surgery
Defibrillation electrode SCHILLER DF87C and DF56C, Leonhard Lang GmbH / SCHILLER Médical SAS
Medical electronics / Electromedical devices – electrotherapy
Batch / lot recall of LMA MAD Nasal Intranasal Mucosal Atomization Device, Teleflex Medical
Physical therapy – inhalation therapy
Batch / lot recall of LMA Mucosal Atomization Devices, Teleflex Medical
Physical therapy – inhalation therapy
Lot recall of MicroTrak Syphilis TPHA 100 / 200 / 500, Trinity Biotech
In-vitro diagnostics – microbiological products
Lot recall of Xpert MRSA / SA BC, Cepheid
In-vitro diagnostics – microbiological products
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