Аналіз інформації за період 01.12.2015 – 31.12.2015, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Опубліковано 18.01.2016 о 00:00


Safety Notice for the ECG electrode, Leonhard Lang GmbH

Urgent Safety Notice for surgical light spring arms (HANAULUX, MAQUET ALM XTEN), Maquet

Corrective action for the CardioCall ECG Event Recorder, Spacelabs Healthcare

Urgent Safety Notice Stratus® CS Acute Care™ Diagnostics System, Siemens Healthcare Diagnostics Inc.

Corrective action for the ARCTIC SUN® 5000 Temperature Management System, Bard Medical Division

Recall for TRACOE larynx stoma button and TRACOE larynx grid button, Tracoe medical GmbH

Recall for all FEHLING MNU-1V – Flexible holding device f. sternum / thorax retractor, FEHLING INSTRUMENTS

Safety Notice for the AnyScan S, SC, SCP products, Mediso

Recall for the Allura Xper FD R8.2.1.1, Philips Medical Systems

Recall for the Allura Xper ED R2.x, Philips Medical Systems

Urgent Safety Notice for the C-arc brake of the Allura Xper R8.2 FD2OC, Philips Medical Systems

Recall of the PFN/PFNA Insertion Handle, Synthes GmbH


Recall of the Persona EM Proximal Tube and Persona EM Distal Rod, Zimmer Biomet

Corrective action for the optimys stems lateral, Mathys Ltd. Bettlach

Urgent Safety Notice for the Electrical Lift Table, IBA Dosimetry GmbH

Urgent Safety Notice for the Aquilion Prime CT scanner, Toshiba Medical Systems

Urgent Safety Notice for the CARTOSOUND® Module of the CARTO® 3 EP Navigation System, Biosense Webster

Recall for certain lots of 9Fr ACUITY Pro Coronary Sinus Outer Guide Catheters, Boston Scientific

Urgent Safety Notice for Baylis Medical ProTrackMicrocatheter, Baylis Medical Company

Urgent Safety Notice concerning the SM straight stem, aap Implantate AG

Urgent Safety Notice for the Breas Vivo 60 Home Care Ventilator, Breas Medical AB

Recall for three flexible instruments (Flexible Drill, Screw Driver and Bone Awl), Aesculap AG

Corrective action for certain HeartStart MRx defibrillator/monitors, Philips Healthcare

Recall and replacement campaign for the main connection cable, Hocoma AG


Corrective action – Update for Alcon 23G and 25G Valved Trocar Entry Systems, 23G & 25+® CONSTELLATION® TOTALPLUS® Paks and CUSTOM-PAK® containing the above mentioned products, Alcon

Recall for ICP – Monitors, Spiegelberg GmbH & Co. KG

Safety Notice for the Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin, Oxoid Limited (part of Thermo Fisher Scientific)

Safety Notice for BD Plastipak™ Syringes and BD™ Oral Syringes, Medline International

Safety Notice for the BARRIER® EasyWarm® products, Mölnlycke Health Care

Safety Notice for the High Pressure Stopcocks, ArcRoyal

Recall for the OLYMPUS ENDOEYE HD II video telescopes, OLYMPUS

Recall for the Osteo-Site® Murphy Side Bevel Bone Biopsy Needle Set, Cook Medical

Recall of various Nebulizers and Nebulization Kits including Opti-Mist / Economist II, ConvaTec/Unomedical

Recall for the SynReam Medullary Reamer Head, Ø 13.5 mm, DePuy Synthes

Urgent Safety Information regarding burrs, Richard Wolf GmbH

Safety Notice for the product GlucoMen® LX Sensor – updated Instructions for Use (IFU) -, A. Menarini Diagnostics

Safety Notice / Recall for HOYA iSert IOLs, HOYA Surgical Optics GmbH

Corrective action for the BIRMINGHAM HIP™ Modular Head (monoblock BHMH), Smith & Nephew Orthopaedics Ltd.

Urgent Safety Notice for the VITROS® 3600 and 5600 Systems Software Version 3.2 & Below, Ortho Clinical Diagnostics

Urgent Safety Notice for the Optitrol A Multimarker Control, DiaMex GmbH

Corrective action for the Dimension Vista® System Flex® reagent cartridge and urine stabilizer B2MIC, Siemens Healthcare Diagnostics


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