Аналіз інформації за період 01.01.2016 – 30.01.2016, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик
Опубліковано 17.02.2016 о 00:00
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Urgent field safety notice for QUADROX-iD Adult/Small Adult, HLS Set Advanced / HIT Set Advanced, PLS Set / HIT Set PLS / HIT Set PLS Plus, Maquet Cardiopulmonary GmbH
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for Spiral Line ProSet, B. Braun Melsungen AG
Injections / Infusions / Transfusions / Dialysis – infusion technology
Field safety notice for Dialog+ SW 9.xx Dialysis Machines, B. Braun Avitum AG
Injections / Infusions / Transfusions / Dialysis – dialysis technology
Field Safety Notice for Chariot Guiding Sheath, Boston Scientific International S. A.
Injections / Infusions / Transfusions / Dialysis – catheters
Corrective action for DGDE DirectGuide Drill Extender, Implant Direct Sybron Manufacturing LLC
Dental products – dental implants
Corrective action for AlignRT/GateRT, VisionRT Ltd.
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Urgent Field Safety Notice for Destination Renal Guiding Sheath, Terumo Europe N. V.
Injections / Infusions / Transfusions / Dialysis – catheters
Urgend Field Safety Notice for Sysmex CA-/CS-Systems with Factor VIII Chromogenic Assay lot, Siemens Healthcare Diagnostics Products GmbH
In-vitro diagnostics – haematological, histological and cytological products
Brain Metastases Version 1.0.0 and Adaptive Hybrid Surgery Analysis Version 1.0.0, Brainlab AG
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Recall of attachment for acetabular and medullary reaming, DePuy Synthes
Medical instruments for use in humans – bone surgery
Urgent safety notice Allura Xper FD R8.2.0, Philips Healthcare
Radiological technology – radiological equipment for vascular diagnostics
Corrective action for proGAV / proGAV 2.0, Christoph Miethke GmbH & Co. KG
Non-active implants – special implants
Corrective action for Medfusion Stopcocks, Smiths Medical
Injections / Infusions / Transfusions / Dialysis – infusion kits
Important follow-up for corrective action for the surgical system drapes manufactured by Microtek Medical used with the da Vinci Surgical Systems, Intuitive Surgical
Surgical equipment/ Anaesthesia – surgical equipment
Safety notice for pressure regulator Swiss optio varius, GLOOR AG
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Urgent field safety notice to syngo RT Therapist / syngo RT Oncologist, Siemens AG
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Safety advisory notice for quench line of superconducting magnets, Siemens Healthcare GmbH
Electromedical fields – equipment for MR tomography
Urgent field safety notice for Bond Polymer Refine Red Detection, Leica Biosystems Newcastle Ltd.
In-vitro diagnostics – immunological products
Corrective action for CONTOUR NEXT control solutions, Bayer HealthCare / Diabetes Care
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice für Absorb and Absorb GT1 Bioresorbable Vascular Scaffold (BVS) Systems, Abbott Vascular
Non-active implants – special implants
Recall of MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE® 30 Blue Curved Tip Cartridge, CARDICA GmbH
Medical instruments for use in humans – general instruments
Urgent field safety notice for Etest PIP/TAZO/CON‐4 PTC 256, bioMérieux SA
In-vitro diagnostics – microbiological products
Urgent field safety notice for Optima CL323i and Optima IGS 320 systems, GE Healthcare
Radiological technology – radiological equipment for vascular diagnostics
Urgent field safety notice for Y Connector 8-10mm, Vygon (UK) Ltd.
Injections / Infusions / Transfusions / Dialysis – infusion technology
Urgent field safety notice for A. V. Fistula sets for Hemodialysis, Asahi Kasei Medical Europe GmbH / Kawasumi Laboratories Inc.
Injections / Infusions / Transfusions / Dialysis – injection kits
Urgent field corrective action for ADVIA Centaur / ADVIA Centaur XP, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Cellistypt, Cellistypt D-K and Cellistypt F, Synthesia a. s. / BBraun Surgical, S. A.
Dressings / Pads – ointments and gels
Field safety notice for Natrelle 133 Plus Tissue Expanders, Allergan
Non-active implants – special implants
Urgent field safety notice for A. V. Fistula sets, Kawasumi Laboratories Inc. / MPS Medical Product Service Gmbh
Injections / Infusions / Transfusions / Dialysis – injection kits
Recall of Radiographic Transparency for Certain and External Connection Tapered Implants, BIOMET 3i
Radiological technology – radiological equipment for stomatological diagnostics
Urgent field safety notice for Allura Xper FD R8.1.15, R8.1.16 and R7.2.8, Philips Healthcare
Radiological technology – radiological equipment for vascular diagnostics
Batch recall for Borehole Port, Christoph Miethke GmbH & Co. KG
Non-active implants – special implants
Urgent field safety notice for Allura Xper / AIIura Centron / Allura Clarity / CV2O, Philips Healthcare
Radiological technology – radiological equipment for vascular diagnostics
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