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

PDF2MB

Urgent field safety notice for Spiral Line ProSet, B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF44KB

Field safety notice for Dialog+ SW 9.xx Dialysis Machines, B. Braun Avitum AG

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF112KB

Field Safety Notice for Chariot Guiding Sheath, Boston Scientific International S. A.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF587KB

Corrective action for DGDE DirectGuide Drill Extender, Implant Direct Sybron Manufacturing LLC

Dental products – dental implants

PDF130KB

Corrective action for AlignRT/GateRT, VisionRT Ltd.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF388KB

Urgent Field Safety Notice for Destination Renal Guiding Sheath, Terumo Europe N. V.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF104KB

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

PDF695KB

Brain Metastases Version 1.0.0 and Adaptive Hybrid Surgery Analysis Version 1.0.0, Brainlab AG

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF597KB

Recall of attachment for acetabular and medullary reaming, DePuy Synthes

Medical instruments for use in humans – bone surgery

PDF62KB

Urgent safety notice Allura Xper FD R8.2.0, Philips Healthcare

Radiological technology – radiological equipment for vascular diagnostics

PDF107KB

Corrective action for proGAV / proGAV 2.0, Christoph Miethke GmbH & Co. KG

Non-active implants – special implants

PDF2MB

Corrective action for Medfusion Stopcocks, Smiths Medical

Injections / Infusions / Transfusions / Dialysis – infusion kits

PDF186KB

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

PDF646KB

Safety notice for pressure regulator Swiss optio varius, GLOOR AG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF223KB

Urgent field safety notice to syngo RT Therapist / syngo RT Oncologist, Siemens AG

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF24KB

Safety advisory notice for quench line of superconducting magnets, Siemens Healthcare GmbH

Electromedical fields – equipment for MR tomography

PDF1MB

Urgent field safety notice for Bond Polymer Refine Red Detection, Leica Biosystems Newcastle Ltd.

In-vitro diagnostics – immunological products

PDF1MB

Corrective action for CONTOUR NEXT control solutions, Bayer HealthCare / Diabetes Care

In-vitro diagnostics – equipment / products for clinical chemistry

PDF184KB

Urgent field safety notice für Absorb and Absorb GT1 Bioresorbable Vascular Scaffold (BVS) Systems, Abbott Vascular

Non-active implants – special implants

PDF737KB

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

PDF146KB

Urgent field safety notice for Etest PIP/TAZO/CON4 PTC 256, bioMérieux SA

In-vitro diagnostics – microbiological products

PDF534KB

Urgent field safety notice for Optima CL323i and Optima IGS 320 systems, GE Healthcare

Radiological technology – radiological equipment for vascular diagnostics

PDF75KB

Urgent field safety notice for Y Connector 8-10mm, Vygon (UK) Ltd.

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF227KB

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

PDF869KB

Urgent field corrective action for ADVIA Centaur / ADVIA Centaur XP, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF40KB

Urgent field safety notice for Cellistypt, Cellistypt D-K and Cellistypt F, Synthesia a. s. / BBraun Surgical, S. A.

Dressings / Pads – ointments and gels

PDF266KB

Field safety notice for Natrelle 133 Plus Tissue Expanders, Allergan

Non-active implants – special implants

PDF29KB

Urgent field safety notice for A. V. Fistula sets, Kawasumi Laboratories Inc. / MPS Medical Product Service Gmbh

Injections / Infusions / Transfusions / Dialysis – injection kits

PDF379KB

Recall of Radiographic Transparency for Certain and External Connection Tapered Implants, BIOMET 3i

Radiological technology – radiological equipment for stomatological diagnostics

PDF226KB

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

PDF134KB

Batch recall for Borehole Port, Christoph Miethke GmbH & Co. KG

Non-active implants – special implants

PDF341KB

Urgent field safety notice for Allura Xper / AIIura Centron / Allura Clarity / CV2O, Philips Healthcare

Radiological technology – radiological equipment for vascular diagnostics

PDF326KB

 

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