Аналіз інформації за період 01.07.2015 – 31.07.2015, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724&gtp=3494768_list%253D6

·                     2015.07.30 Safety Notice for the Fine Pressure Regulator, Synthes GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply PDF4MB

·                     2015.07.30 Corrective action for the Allura Xper system, Philips Healthcare

Radiological technology – radiological equipment for vascular diagnostics PDF301KB

·                     2015.07.30 Safety Notice for the Trinder reagents (package inserts for the products will be updated), DIALAB GmbH

In-vitro diagnostics – equipment / products for clinical chemistry PDF131KB

·                     2015.07.30 Recall for the Aspen/Alpine and Lineum Torque Handles, Biomet Spine LLC

Medical instruments for use in humans – bone surgery PDF621KB

·                     2015.07.30 Recall for KYPHON® 11 Gauge Bone Access Needles, Medtronic on behalf of Argon Medical

Medical instruments for use in humans – bone surgery PDF95KB

·                     2015.07.30 Corrective action for the Philips HeartStart XL+ Defibrillator/Monitor, Philips Healthcare

Medical electronics / Electromedical devices – electrotherapy PDF110KB

·                     2015.07.30 Updated Information for Crea A and Crea B membrane units, RADIOMETER

In-vitro diagnostics – equipment / products for clinical chemistry PDF22KB

·                     2015.07.29 Corrective action for the Reflotron Uric Acid test, Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry PDF74KB

·                     2015.07.29 Corrective action for the ADVIA Centaur XPT System, Siemens Healthcare Diagnostics

In-vitro diagnostics – equipment / products for clinical chemistry PDF157KB

·                     2015.07.29 Safety Notice for the Össur prosthetic feet with attached aluminum male adapter, Össur hf

Orthopaedic / Rehabilitation technology – prostheses (exoprostheses) PDF105KB

·                     2015.07.29 Recall for the Modular Knee Joint, Otto Bock HealthCare GmbH

Orthopaedic / Rehabilitation technology – prostheses (exoprostheses) PDF111KB

·                     2015.07.29 Recall for the Gazin® Balls 2+3 and Gazin® Balls 2+2, Lohmann & Rauscher GmbH & Co. KG

Dressings / Pads – swabs, sponges, wipes, swabsticks PDF57KB

·                     2015.07.28