Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2016 – 31.10.2016

Опубліковано 06.12.2016 о 00:00


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Urgent field safety notice for SOMATOM Definition AS and SOMATOM Definition Flash, Siemens Healthcare GmbH

Radiological technology – CT scanners

PDF128KB

Urgent field safety notice for SOMATOM Definition AS and SOMATOM Definition Flash, Siemens Healthcare GmbH

Radiological technology – CT scanners

PDF126KB

Urgent field safety notice for Femoral and Tibial Cutting Block Adapter, Brainlab AG

Radiological technology – navigation systems

PDF277KB

Lot recall of QMS Everolimus Immunoassay, Thermo Fisher Scientific / Microgenics Corporation

In-vitro diagnostics – equipment / products for clinical chemistry

PDF107KB

Lot recall of Cholinesterase FS, DiaSys Diagnostic Systems GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF176KB

Urgent field safety notice for RayStation 5, RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF302KB

Urgent field safety notice for Innova 2100IQ / 3100 / 3100IQ / 4100 / 4100IQ, GE Healthcare

Radiological technology – radiological equipment for vascular diagnostics

PDF428KB

Urgent field safety notice for IACS SW Version VG5.0, Draeger Medical Systems Inc.

Medical electronics / Electromedical devices – electrodiagnostics

PDF122KB

Urgent field safety notice for Biosen Glucose / Lactate Consumables, EKF-diagnostic GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF144KB

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

PDF218KB

Urgent field safety notice for boso TM-2430 PC2, Bosch + Sohn GmbH u. Co. KG

Medical electronics / Electromedical devices – electronic blood pressure monitor

PDF13KB

Lot recall of DRI Salicylate Serum Tox Assay, Thermo Fisher Scientific / Microgenics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF394KB

Urgent field safety notice for GLU / LAC / UREA (BUN) Cassette, Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF77KB

Urgent field safety notice for Prometra programmable pump (REF 91827), Flowonix Medical Inc.

Active implantable medical devices – drug pumps

PDF344KB

Urgent field safety notice for central axis system, S.I.M.E.O.N.

Surgical equipment/ Anaesthesia – surgical equipment

PDF353KB

Urgent field safety notice for CPX4 Medium Height Breast Tissue Expander 650 cc, Mentor

Non-active implants – special implants

PDF126KB

Urgent field safety notice for Brilliance 64 and Ingenuity CT / Core / Core128, Philips Healthcare

Radiological technology – CT scanners

PDF127KB

Urgent field safety notice for Chemistry Calibrator, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF84KB

Lot recall of PATHFAST Myoglobin, Mitsubishi Chemical Europe GmbH

In-vitro diagnostics – immunological products

PDF121KB

Lot recall of NADAL RSV rapid test, nal von minden GmbH

In-vitro diagnostics – microbiological products

PDF277KB

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

PDF388KB

Lot recall of SelectiCure L19, 3M Deutschland GmbH

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF154KB

Urgent field safety notice for FACET WEDGE, DePuy Synthes / Synthes GmbH

Non-active implants – bone surgery

PDF278KB

Recall of IBS-TITAN TLIF II, Peter Brehm GmbH

Non-active implants – bone surgery

PDF154KB

Urgent field safey notice for Dialog+ Dialysis Machines with Software 8.2A, B. Braun

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF36KB

Batch recall of ORG 908MX Anti Mumps Virus IgM, ORGENTEC Diagnostika GmbH

In-vitro diagnostics – microbiological products

PDF234KB

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

PDF148KB

Urgent field safety notice for Devon Light Glove, Medtronic / Covidien

Surgical equipment/ Anaesthesia – surgical equipment

PDF374KB

Urgent field safety notice for Devon Light Glove, Medtronic / Covidien

Surgical equipment/ Anaesthesia – surgical equipment

PDF183KB

Urgent field safety notice for ARCHITECT Lactic Acid reagent, Abbott Laboratories

In-vitro diagnostics – equipment / products for clinical chemistry

PDF26KB

Urgent field safety notice for Model 37751 Recharger included in Model 37651 Charging System, Medtronic

Active implantable medical devices – biostimulators

PDF144KB

Urgent field safety notice for Algovita Spinal Cord Stimulation System, Nuvectra

Active implantable medical devices – biostimulators

PDF357KB

Lot recall of Reducer Kit, Neovasc

Non-active implants – special implants

PDF26KB

Lot recall of gabControl D-Dimer rapid test (M09DD02), gabmed GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF146KB

Urgent field safety notice for IntelliVue MX40, Philips Healthcare

Medical electronics / Electromedical devices – electrodiagnostics

PDF236KB

Batch recall of AV-Set B-R, Fresenius Medical Care

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF36KB

Urgent field safety notice for Combi Dockable Table Neurosurgery, Siemens Healthcare GmbH

Electromedical fields – equipment for MR tomography

PDF222KB

Lot recall of PT Owren’s GHI131-10 SI, MediRox AB

In-vitro diagnostics – haematological, histological and cytological products

PDF115KB

Urgent field safety notice for Vitamin D Total, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF38KB

Lot recall of Trident Universal Impactor / Positioner, Stryker Orthopaedics

Medical instruments for use in humans – bone surgery

PDF81KB

Lot recall of sterile Reaming Rods for SynReam, DePuy Synthes / Synthes GmbH

Medical instruments for use in humans – bone surgery

PDF301KB

Recall of Guider Guide Catheter, Stryker Neurovascular

Injections / Infusions / Transfusions / Dialysis – catheters

PDF30KB

Lot recall of drill dia. 1.9 mm, lntegra LifeSciences Services (France)

Medical instruments for use in humans – bone surgery

PDF248KB

Recall of LAA Occluder, Occlutech International AB

Non-active implants – cardiac surgery

PDF190KB

Recall of SONNET Rechargeable Battery Pack Cover Micro Black, MED-EL Elektromedizinische Geräte GmbH

Active implantable medical devices – biostimulators

PDF125KB

Lot recall of Pop-On Self-Adhering Male External Catheter, C. R. Bard Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF47KB

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

PDF101KB

Lot recall of MicroTrak Syphilis TPHA PK, Trinity Biotech Manufacturing Limited

In-vitro diagnostics – microbiological products

PDF166KB

Urgent field safety notice for Aptio Automation Modules, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF24KB

Urgent field safety notice for surgical tables axis 400-800, Schaerer Medical AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF280KB

Lot recall of MUTARS filia prox. femur incl. safety screw, implantcast GmbH

Non-active implants – bone surgery

PDF49KB

Batch recall of Innex Knee System / Tibial Alignment Guide Proximal, Zimmer Biomet / Zimmer GmbH

Medical instruments for use in humans – bone surgery

PDF97KB

Urgent field safety notice for Flashlite Magna 4.0, DenMat / American Dental Systems GmbH

Dental products – equipment

to the article

Urgent field safety notice for TCM5 FLEX and TCM5 BASIC, Radiometer

Medical electronics / Electromedical devices – electrodiagnostics

PDF116KB

Urgent field safety notice for Ultrasonic Endoscope EG-530UT2 / EG-530UR2, FUJIFILM / Aquilant Endoscopy

Optics / Precision engineering – endoscopes

PDF47KB

Urgent field safety notice for BLOTrix 3.4, BioSciTec GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF360KB

Urgent field safety notice for MicroTrak Syphilis TPHA PK, Trinity Biotech

In-vitro diagnostics – microbiological products

PDF561KB

Urgent field safety notice for Evidence lnvestigator EV3602, Randox Laboratories Ltd.

Medical data processing (software) – others

PDF61KB

Urgent field safety notice for proGAV 2.0, Christoph Miethke GmbH & Co. KG

Non-active implants – special implants

PDF273KB

Lot recall of EZ-Tip, Research Instruments Limited

In vitro fertilization – others

PDF111KB

Urgent field safety notice for Synapse PACS software, FUJIFILM Medical Systems USA Inc.

Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine

PDF120KB

Recall of PFO-Occluders, Acoredis GmbH

Non-active implants – cardiac surgery

PDF593KB

Recall and after-care recommendation for WATCHMAN FLX Left Atrial Appendage (LAAC) Closure Device, Boston Scientific International S.A.

Non-active implants – cardiac surgery

PDF139KB

Lot recall of NexGen LPS Femoral, Zimmer Biomet / Zimmer GmbH

Non-active implants – bone surgery

PDF197KB

Urgent field safey notice for FindrWIRZ, SentreHEART Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF94KB

Urgent field safety notice for ProcedurePak kits and trays, Mölnlycke Health Care

Dressings / Pads – others

PDF139KB

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

Medical electronics / Electromedical devices – electrotherapy

PDF386KB

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

PDF593KB

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

PDF357KB

Urgent field safety notice for iPlan RT Radiation Treatment Planning Software, Brainlab AG

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF228KB

Urgent field safety notice for Dimension Vista System Chemistry 1 Calibrator, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF92KB

 

 

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