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
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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
CORRECTIVE ACTION FOR THE CYTO LUER SET, BAXTER HEALTHCARE
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 ProTrack™ Microcatheter, 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
REVISED LABELING FOR THE OLYMPUS GF-UCT180 GASTROVIDEOSCOPE, OLYMPUS
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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