Аналіз інформації за період 01.09.2015 – 30.09.2015, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

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·                     2015.09.21 Recall for the Target Coils, Stryker Neurovascular

Non-active implants – special implants PDF99KB

 

·                     2015.09.21 Urgent Safety Notice for MATResponder Tourniquet, Pyng Medical Corp.

General equipment for medical treatment – medico-mechanical devices PDF43KB

 

·                     2015.09.21 Safety Notice for the KIMVENT* Closed Suction Systems, Halyard Health

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply PDF295KB

 

·                     2015.09.21 Safety Notice for the Brilliance 64 and Ingenuity CT Scanners, Philips Healthcare

Radiological technology – CT scanners PDF55KB

 

·                     2015.09.21 Safety Notice regarding MCS-Port Obturator / MCS5000, A. M. I. Agency for Medical Innovations GmbH

Injections / Infusions / Transfusions / Dialysis – catheters PDF66KB

 

·                     2015.09.21 Recall for the Aliquot Delivery Kits (Syringe and Plunger), Stryker® Orthobiologics

General equipment for medical treatment – auxiliary equipment PDF55KB

 

·                     2015.09.21 Recall for the product Cutilyth sensitve Gel / Neutrosteralyth-Gel, AQUIS GmbH

Dressings / Pads – ointments and gels PDF82KB

 

·                     2015.09.21 Safety Corrective Action/Recall for PORT-A-CATH® Plastic Hub Needles, Smiths Medical

Injections / Infusions / Transfusions / Dialysis – injection kits PDF242KB

 

·                     2015.09.21 Important Safety Notice for the XiO RTP System, IMPAC Medical Systems, Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems PDF35KB

 

·                     2015.09.21 Important Information for the Accu-Chek Insight system, Roche Diabetes Care

Injections / Infusions / Transfusions / Dialysis – infusion technology PDF200KB

 

·                     2015.09.21 Corrective action for the Valved Entry Systems sold as stand-alone, within CONSTELLATION® TOTALPLUS® Paks, and within Alcon CUSTOM-PAKS, Alcon Laboratories Inc.

ophthalmological technology – equipment for ophthalmological therapeutics PDF130KB

 

·                     2015.09.16 Recall for the ThruPort™ Knot Pusher Model KP1 and Valve Placement Pack Model VPP, Edwards Lifesciences LLC

Medical instruments for use in humans – cardiac/thorax surgery PDF52KB

 

·                     2015.09.16 Recall for the Actifuse ABX, Actifuse MIS System and Inductigraft products, Baxter Healthcare Corporation

Non-active implants – materials for implants PDF175KB

 

·                     2015.09.16 Corrective action for the iChemVELOCITY Urine Chemistry Strips, Iris International

In-vitro diagnostics – equipment / products for clinical chemistry PDF199KB

 

·                     2015.09.16 Urgent Safety Notice for the Neptune® 2 Docker (STRYKER NEPTUNE® 2 WASTE MANAGEMENT SYSTEM), Stryker Instruments

Surgical equipment/ Anaesthesia – surgical equipment PDF454KB

 

·                     2015.09.16 Recall for the Idylla™ KRAS Mutation Test, Biocartis

In-vitro diagnostics – immunological products PDF3MB

 

·                     2015.09.16 Urgent Safety Notice for the Digital Radiography X-Ray Systems DR 400, Agfa Healthcare N.V.

Radiological technology – stationary radiological equipment PDF35KB

 

·                     2015.09.15 Recall for the product Genu Arexa, Otto Bock HealthCare GmbH

Orthopaedic / Rehabilitation technology – orthoses PDF241KB

 

·                     2015.09.15 Urgent Safety Notice for the Medtronic CryoConsole, Medtronic

Medical electronics / Electromedical devices – electrotherapy PDF42KB

 

·                     2015.09.15 Urgent Safety Notice for the Cuff Controller (Shiley Pressure Control), VBM Medizintechnik GmbH

Medical electronics / Electromedical devices – electronic blood pressure monitor PDF2MB

 

·                     2015.09.10 Field Safety Notification for DePuy Synthes-Reamer/Irrigator/Aspirator-System (RIA), DePuy Synthes

Medical instruments for use in humans – bone surgery PDF3MB

 

·                     2015.09.10 Urgent Safety Notice for Neopterin EIA, Brahms GmbH

In-vitro diagnostics – immunological products PDF118KB

 

·                     2015.09.10 Field Safety Notice for Flexi-Slip™ Endotracheal Tube Stylet, Teleflex Medical

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply PDF311KB

 

·                     2015.09.08 Update of the Safety Information (published 7.1.15) for St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ Implantable Cardioverter Defibrillators (ICDs) and Assurity™and Allure™ Pacemakers

Active implantable medical devices – defibrillators PDF58KB

 

·                     2015.09.03 Corrective action for the product Nit-Occlud Implantation Sheath, pfm medical mepro gmbh

Injections / Infusions / Transfusions / Dialysis – catheters PDF2MB

 

·                     2015.09.03 Urgent Safety Notice for the Cholesterol FS, Creatinine PAP FS and for the other tests based on trinder reactions, DiaSys Diagnostic Systems GmbH

In-vitro diagnostics – equipment / products for clinical chemistry PDF101KB

 

·                     2015.09.03 Recall for the silicon tube 1008, Hippokratec GmbH

Physical therapy – insufflation technique PDF22KB

 

·                     2015.09.03 Urgent Safety Notice for the ceiling pendants SPR10, MZ Liberec a.s.

Surgical equipment/ Anaesthesia – surgical equipment PDF2MB

 

·                     2015.09.02 Urgent Safety Notice for the MICTEC Hook electrode, DUFNER Instrumente GmbH

Medical electronics / Electromedical devices – electrotherapy PDF2MB

 

·                     2015.09.02 Urgent Safety Notice for Hitachi MRI Systems AIRIS Vento, AIRIS Vento LT, APERTO Eterna, APERTO Lucent, Echelon and Oasis, Hitachi Medical Corporation

Electromedical fields – equipment for MR tomography PDF249KB

 

·                     2015.09.02 Urgent Safety Notice for the JenaValve prosthesis, JenaValve Technology GmbH

Non-active implants – cardiac surgery PDF172KB

 

·                     2015.09.02 Corrective action for RUSSKA Rollator Standard and Rollator Aluminium, Ludwig Bertram GmbH

Orthopaedic / Rehabilitation technology – daily living aids PDF34KB

 

·                     2015.09.02 Corrective action for the Covidien Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes, Covidien/Medtronic

Medical electronics / Electromedical devices – electrotherapy PDF115KB

 

·                     2015.09.02 Safety Notice for the METHA Titanium Cone Adapter (Neck), Aesculap AG

Non-active implants – bone surgery PDF407KB