Людям із порушенням зору 
In English Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2017 – 31.03.2017
Опубліковано 31.03.2017 о 00:00
Німеччина
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Lot recall of INFASID®-P plus 190, ASID BONZ GmbH
Injections / Infusions / Transfusions / Dialysis – filters
Lot recall of 1mL Medallion® syringes, Merit Medical Inc.
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Urgent field safety notice for LIFEPAK® Defibrillator, Physio-Control Netherlands B.V.
Medical electronics / Electromedical devices – electrotherapy
Urgent field safety notice for Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0. / Vivid S70/S60 with software version 201, revision 55.0 and 63.0. / Vivid S70N/S60N with software version 201, revision 63.0., GE Healthcare
Ultrasonics – ultrasonic diagnostic equipment
Urgent field safety notice for Solus Flexible – small paediatric, wire-reinforced laryngeal mask airway 2 / large paediatric, wire-reinforced laryngeal mask airway 2.5 / small adult, wire-reinforced laryngeal mask airway 3 / medium adult, wire-reinforced laryngeal mask airway 4 / large adult, wire-reinforced laryngeal mask airway 5, Intersurgical Ltd.
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Lot recall of UrgoClean Ag, URGO GmbH
Dressings / Pads – dressings
Lot recall of ERGO handle, Erbe Elektromedizin GmbH
Medical electronics / Electromedical devices – electrotherapy
Urgent field safety notice for KleenSpec® Corded Illumination System, Welch Allyn Limited
Medical instruments for use in humans – gynaecology
Urgent field safety notice for atraumatic compact Cysto-Urethroscope 25°, Richard Wolf GmbH
Optics / Precision engineering – endoscopes
Lot recall of Wingman 35 Crossing Catheter, ReFlow Medical
Injections / Infusions / Transfusions / Dialysis – catheters
Urgent field safety notice for LiquiBand® FIX8™, Advanced Medical Solutions
Non-active implants – special implants
Urgent field safety notice for BrightView / BrightView X, BrightView XCT, Philips Medical Systems Inc.
Radiological technology – equipment for nuclear medical functional and localisation diagnostics
Recall of various kits containing ACDA, Zimmer Biomet
Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Urgent field safety notice for Artis zee systems with SW VD 11 and A100 generator, Siemens Healthcare GmbH
Radiological technology – radiological equipment for vascular diagnostics
Urgent field safety notice for defibrillator battery FRED easy, Schiller Medical SAS
Medical electronics / Electromedical devices – electrotherapy
Urgent field safety notice for lithomy basket series “Easy-Catch”, MTW-Endoskopie
Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Urgent field safety notice for Da Vinci® Xi EndoWrist Stapler Release Kit, Intuitive Surgical
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for Robot Imager and Gantry Imager, Siemens Healthcare GmbH
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Lot recall of drill bit f. quick coupling; Ø3.2 x 160 / spiral In 60 / quadr. spiral / cann. / inside / Ø1,7″, Königsee Implantate GmbH
Medical instruments for use in humans – bone surgery
Urgent field safety notice for Codman Microcoil Delivery Systems and Detachment Control Boxes, Johnson & Johnson
Non-active implants – special implants
Batch recall of FLIPPTACK fixation button, KARL STORZ GmbH & Co. KG
Non-active implants – bone surgery
Urgent field safety notice for HIGH / MID PROFILE single compartment cushion with Sensor Ready Technology, ROHO Inc.
Orthopaedic / Rehabilitation technology – mobility aids
Lot recall of cortex screw Ø 3.5 mm / self-tapping / stainless steel / sterile, DePuy Synthes
Non-active implants – bone surgery
Recall of S.M.A.R.T. Flex Vascular Stent System, Cordis Corporation
Non-active implants – special implants
Lot recall of specific knee, hip and nail implants, Zimmer Biomet
Non-active implants – bone surgery
Recall of CombiSets with BD 10 ml Plastipak catheter tip syringe, PAUL HARTMANN AG
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Lot recall of BD Plastipak 100 ml syringe, ArcRoyal
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Lot recall of ACUFEX TRUNAV retrograde drills, Smith & Nephew Inc.
Medical instruments for use in humans – bone surgery
Urgent field safety notice for MDRC-1119 front cover kit, Barco
Medical electronics / Electromedical devices – electrodiagnostics
Urgent field safety notice for HARTMANN VivanoTec / ATMOS S 042 NPWT, Paul Hartmann AG / ATMOS MedizinTechnik GmbH & Co. KG
Surgical equipment/ Anaesthesia – surgical equipment
Lot recall of sterile endoprosthetics products and cancellous screw VariaCup, aap Implantate AG
Non-active implants – bone surgery
Urgent field safety notice for ProGrade, Philips Medizin Systeme
Radiological technology – stationary radiological equipment
Batch recall of PANTA / XL nails, Integra / Newdeal
Non-active implants – bone surgery
Urgent field safety notice for Life-Point AEDs, METsis Medikal Ltd. Sti.
Medical electronics / Electromedical devices – electrotherapy
Urgent field safety notice for ProteusPLUS, IBA
Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
Recall of VarioLoc / SM straight stern / VarioCup hip prostheses, aap Implantate AG
Non-active implants – bone surgery
Lot recall of manometer tray / Jamshidi Needle Biopsy / Illinois (TJ) needle aspiration / Jamshidi (TJ) needle bone marrow / Thoracentesis / Paracentesis kit, BD / CareFusion
Medical instruments for use in humans – bone surgery
Urgent field safety notice for duodenscopes, PENTAX Europe GmbH
Optics / Precision engineering – endoscopes
Lot recall of iASSIST validation tool, Zimmer Biomet / Zimmer CAS
Medical instruments for use in humans – bone surgery
Lot recall of UrgoClean Ag 10×12 OP (20 pieces), URGO GmbH
Dressings / Pads – dressings
Urgent field safety notice for HeartWare ventricular assist device (HVAD) system, Medtronic
Active implantable medical devices – artificial hearts
Recall of StrataMR adjustable valves & shunts, Medtronic GmbH
Non-active implants – special implants
Urgent field safety notice for intensive care ventilators elisa 600, elisa 800 and elisa 800VIT, SALVIA medical GmbH & Co. KG
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Lot recall of Dryline II, Shenzhen Mindray Bio-Medical Electronics Co. Ltd.
Medical electronics / Electromedical devices – electrodiagnostics
Lot / batch recall of ORBITARIS handle, Günter Bissinger Medizintechnik GmbH
Medical electronics / Electromedical devices – electrotherapy
Urgent field safety notice for Alaris PK Plus Syringe Pump, CareFusion
Injections / Infusions / Transfusions / Dialysis – infusion technology
Urgent field safety notice for Efficia CMS200 central monitor system, Philips Healthcare
Medical electronics / Electromedical devices – electrodiagnostics
Lot recall of Vivano Med Abdominal Kits, PAUL HARTMANN AG
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for Hexalon / Trinion / GTR tacks, Inion
Non-active implants – bone surgery
Urgent field safety notice for Accu-Chek Insight insulin pump, Roche Diabetes Care
Injections / Infusions / Transfusions / Dialysis – infusion technology
Urgent field safety notice for Verticale pedicle / iliac screws dia. 8.2 / 9.2 / 10.2 mm, Silony Medical Ltd.
Medical instruments for use in humans – bone surgery
Lot recall of Comprehensive Reverse Shoulder Tray, Zimmer Biomet
Non-active implants – bone surgery
Urgent field safey notice for MiniMed 640G Insulin Infusion Pump, Medtronic
Injections / Infusions / Transfusions / Dialysis – infusion technology
Lot recall of Beacon EUS delivery system needles, Medtronic
Optics / Precision engineering – endoscopes
Lot recall of GyneFix, Gynlameda GmbH
Contraception – intrauterine device
Recall of BD Plastipak Syringe 100 ml with catheter neck, MSP Schmeiser GmbH
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Recall of RSP monoblock / Turon impaction block fixtures, DJO Surgical / MDSS GmbH
Medical instruments for use in humans – bone surgery
Urgent field safety notice for Artis systems with wireless foot switch, Siemens Healthcare GmbH
Radiological technology – radiological equipment for vascular diagnostics
Lot recall of various polyethylene implants, Zimmer Biomet
Non-active implants – bone surgery
Lot recall of 1/3 tubular plate 3.5 / 2 and 3 round holes, aap Implantate AG
Non-active implants – bone surgery
Lot recall of sterile procedure packs containing BD Plastipak syringe 100 ml with catheter tip and Luer adapter, Wagner KG Klinikbedarf / WaWuMed Medizinprodukte / Becton Dickinson GmbH
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Urgent field safety notice for digital linear accelerators ARTISTE / ONCOR / PRIMUS, Siemens Healthcare GmbH
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
Urgent field safety notice for multiFiltratePRO devices, Fresenius Medical Care AG & Co. KGaA
Injections / Infusions / Transfusions / Dialysis – dialysis technology
Urgent field safety notice for DR system GU60A, Samsung Electronics
Radiological technology – stationary radiological equipment
Urgent field safety notice for V60 respiratory ventilator with version 2.20 software, Respironics California LLC / Philips
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Recall of Endurant / Endurant II 23 mm and 25 mm Bifurcated Stent Graft Systems, Medtronic
Non-active implants – special implants
Urgent field safety notice for Danis Procedure Pack / Basic, ELLA-CS s.r.o.
Non-active implants – special implants
Lot recall of Multi-unit Abutment Plus CC RP 25 mm, Nobel Biocare
Dental products – dental implants
Urgent field safety notice for LINEA stems, Tornier SAS
Non-active implants – bone surgery
Recall of pseudophagic intraocular lens A4SW00 acrylic IOL / AddOn / spherical / hydrophilic / clear / -10,0 D to +10,0 D, 1stQ GmbH
Non-active implants – special implants
Lot recall of TS100S Diego Elite Tubeset Standard / TS101DC Diego Elite Tubeset Declog, Olympus
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
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