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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 031 04 11 000
Date submitted: 4/10/2011
Manufacturer:Varian Medical Systems
Device Type:Clinac Linear accelerator
Description:Accelerator System, Linear
Medical Device Identifier:Type 3 hard wedge assembies (Clinac Accessory) – see attached list of possibly affected units
Reason of Field Safety Corrective Action:The wedge angle labeling on the wedge tray may not correctly match the wedge body. In all cases the wedge body is labeled with the correct wedge angle.
Remedy Action:Immediately inspect all wedges to verify that the wedge angle label on the wedge body matches the wedge angle label on the wedge tray.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh (01) 2772126
Report Source:NCMDR
Source Ref. Number:BCCD790C75283
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Manufacturer letter.pdf