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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 008 02 11 000
Date submitted: 2/2/2011
Manufacturer:Nihon Kohden Corp
Device Type:KC 600P Cart, beside Monitor
Description:Monitors, Bedside, Physiologic
Medical Device Identifier:WEP 5200 Telemetry System, BSM 6000 series or PVM 2701 Beside Monitor attached to KC 600P Cart
Reason of Field Safety Corrective Action:A fault in the lock plate of the cart, some lock plate are not thick enough to support the monitor under condition of frequent tilting. In a worst-case situation, the monitor can fall over
Remedy Action:Replace the lock plate with the provided one. Follow the procedure in the installation guide included with the provided lock plate
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB, Riyadh (01) 4793000
Report Source:NCMDR
Source Ref. Number:2773FC4828206
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:No Attachments