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

http://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724

Lot recall of INFASID®-P plus 190, ASID BONZ GmbH

Injections / Infusions / Transfusions / Dialysis – filters

PDF86KB

Lot recall of 1mL Medallion® syringes, Merit Medical Inc.

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF128KB

Urgent field safety notice for LIFEPAK® Defibrillator, Physio-Control Netherlands B.V.

Medical electronics / Electromedical devices – electrotherapy

PDF47KB

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

PDF294KB

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

PDF74KB

Lot recall of UrgoClean Ag, URGO GmbH

Dressings / Pads – dressings

PDF195KB

Lot recall of ERGO handle, Erbe Elektromedizin GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF115KB

Urgent field safety notice for KleenSpec® Corded Illumination System, Welch Allyn Limited

Medical instruments for use in humans – gynaecology

PDF23KB

Urgent field safety notice for atraumatic compact Cysto-Urethroscope 25°, Richard Wolf GmbH

Optics / Precision engineering – endoscopes

PDF219KB

Lot recall of Wingman 35 Crossing Catheter, ReFlow Medical

Injections / Infusions / Transfusions / Dialysis – catheters

PDF118KB

Urgent field safety notice for LiquiBand® FIX8™, Advanced Medical Solutions

Non-active implants – special implants

PDF266KB

Urgent field safety notice for BrightView / BrightView X, BrightView XCT, Philips Medical Systems Inc.

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF244KB

Recall of various kits containing ACDA, Zimmer Biomet

Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells

PDF93KB

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

PDF114KB

Urgent field safety notice for defibrillator battery FRED easy, Schiller Medical SAS

Medical electronics / Electromedical devices – electrotherapy

PDF69KB

Urgent field safety notice for lithomy basket series “Easy-Catch”, MTW-Endoskopie

Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy

PDF21KB

Urgent field safety notice for Da Vinci® Xi EndoWrist Stapler Release Kit, Intuitive Surgical

Surgical equipment/ Anaesthesia – surgical equipment

PDF486KB

Urgent field safety notice for Robot Imager and Gantry Imager, Siemens Healthcare GmbH

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF145KB

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

PDF247KB

Urgent field safety notice for Codman Microcoil Delivery Systems and Detachment Control Boxes, Johnson & Johnson

Non-active implants – special implants

PDF521KB

Batch recall of FLIPPTACK fixation button, KARL STORZ GmbH & Co. KG

Non-active implants – bone surgery

PDF336KB

Urgent field safety notice for HIGH / MID PROFILE single compartment cushion with Sensor Ready Technology, ROHO Inc.

Orthopaedic / Rehabilitation technology – mobility aids

PDF572KB

Lot recall of cortex screw Ø 3.5 mm / self-tapping / stainless steel / sterile, DePuy Synthes

Non-active implants – bone surgery

PDF141KB

Recall of S.M.A.R.T. Flex Vascular Stent System, Cordis Corporation

Non-active implants – special implants

PDF133KB

Lot recall of specific knee, hip and nail implants, Zimmer Biomet

Non-active implants – bone surgery

PDF297KB

Recall of CombiSets with BD 10 ml Plastipak catheter tip syringe, PAUL HARTMANN AG

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF23KB

Lot recall of BD Plastipak 100 ml syringe, ArcRoyal

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF236KB

Lot recall of ACUFEX TRUNAV retrograde drills, Smith & Nephew Inc.

Medical instruments for use in humans – bone surgery

PDF127KB

Urgent field safety notice for MDRC-1119 front cover kit, Barco

Medical electronics / Electromedical devices – electrodiagnostics

PDF244KB

Urgent field safety notice for HARTMANN VivanoTec / ATMOS S 042 NPWT, Paul Hartmann AG / ATMOS MedizinTechnik GmbH & Co. KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF298KB

Lot recall of sterile endoprosthetics products and cancellous screw VariaCup, aap Implantate AG

Non-active implants – bone surgery

PDF1MB

Urgent field safety notice for ProGrade, Philips Medizin Systeme

Radiological technology – stationary radiological equipment

PDF196KB

Batch recall of PANTA / XL nails, Integra / Newdeal

Non-active implants – bone surgery

PDF339KB

Urgent field safety notice for Life-Point AEDs, METsis Medikal Ltd. Sti.

Medical electronics / Electromedical devices – electrotherapy

PDF584KB

Urgent field safety notice for ProteusPLUS, IBA

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF64KB

Recall of VarioLoc / SM straight stern / VarioCup hip prostheses, aap Implantate AG

Non-active implants – bone surgery

PDF578KB

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

PDF369KB

Urgent field safety notice for duodenscopes, PENTAX Europe GmbH

Optics / Precision engineering – endoscopes

PDF39KB

Lot recall of iASSIST validation tool, Zimmer Biomet / Zimmer CAS

Medical instruments for use in humans – bone surgery

PDF327KB

Lot recall of UrgoClean Ag 10×12 OP (20 pieces), URGO GmbH

Dressings / Pads – dressings

PDF634KB

Urgent field safety notice for HeartWare ventricular assist device (HVAD) system, Medtronic

Active implantable medical devices – artificial hearts

PDF270KB

Recall of StrataMR adjustable valves & shunts, Medtronic GmbH

Non-active implants – special implants

PDF243KB

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

PDF127KB

Lot recall of Dryline II, Shenzhen Mindray Bio-Medical Electronics Co. Ltd.

Medical electronics / Electromedical devices – electrodiagnostics

PDF93KB

Lot / batch recall of ORBITARIS handle, Günter Bissinger Medizintechnik GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF148KB

Urgent field safety notice for Alaris PK Plus Syringe Pump, CareFusion

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF44KB

Urgent field safety notice for Efficia CMS200 central monitor system, Philips Healthcare

Medical electronics / Electromedical devices – electrodiagnostics

PDF46KB

Lot recall of Vivano Med Abdominal Kits, PAUL HARTMANN AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF22KB

Urgent field safety notice for Hexalon / Trinion / GTR tacks, Inion

Non-active implants – bone surgery

PDF48KB

Urgent field safety notice for Accu-Chek Insight insulin pump, Roche Diabetes Care

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF102KB

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

PDF760KB

Lot recall of Comprehensive Reverse Shoulder Tray, Zimmer Biomet

Non-active implants – bone surgery

PDF216KB

Urgent field safey notice for MiniMed 640G Insulin Infusion Pump, Medtronic

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF126KB

Lot recall of Beacon EUS delivery system needles, Medtronic

Optics / Precision engineering – endoscopes

PDF114KB

Lot recall of GyneFix, Gynlameda GmbH

Contraception – intrauterine device

PDF75KB

Recall of BD Plastipak Syringe 100 ml with catheter neck, MSP Schmeiser GmbH

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF215KB

Recall of RSP monoblock / Turon impaction block fixtures, DJO Surgical / MDSS GmbH

Medical instruments for use in humans – bone surgery

PDF189KB

Urgent field safety notice for Artis systems with wireless foot switch, Siemens Healthcare GmbH

Radiological technology – radiological equipment for vascular diagnostics

PDF103KB

Lot recall of various polyethylene implants, Zimmer Biomet

Non-active implants – bone surgery

PDF171KB

Lot recall of 1/3 tubular plate 3.5 / 2 and 3 round holes, aap Implantate AG

Non-active implants – bone surgery

PDF646KB

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

PDF243KB

Urgent field safety notice for digital linear accelerators ARTISTE / ONCOR / PRIMUS, Siemens Healthcare GmbH

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF34KB

Urgent field safety notice for multiFiltratePRO devices, Fresenius Medical Care AG & Co. KGaA

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF162KB

Urgent field safety notice for DR system GU60A, Samsung Electronics

Radiological technology – stationary radiological equipment

PDF191KB

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

PDF114KB

Recall of Endurant / Endurant II 23 mm and 25 mm Bifurcated Stent Graft Systems, Medtronic

Non-active implants – special implants

PDF43KB

Urgent field safety notice for Danis Procedure Pack / Basic, ELLA-CS s.r.o.

Non-active implants – special implants

PDF204KB

Lot recall of Multi-unit Abutment Plus CC RP 25 mm, Nobel Biocare

Dental products – dental implants

PDF108KB

Urgent field safety notice for LINEA stems, Tornier SAS

Non-active implants – bone surgery

PDF467KB

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

PDF48KB

Lot recall of TS100S Diego Elite Tubeset Standard / TS101DC Diego Elite Tubeset Declog, Olympus

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF163KB

 

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