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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 094 01 12 000
Date submitted: 1/25/2012
Manufacturer:Varian Medical Systems
Device Type:Radiotherapy Systems, Linear Accelerator, C-Series Clinac and Trilogy Linear Accelerators
Description:Radiotherapy Systems, Linear Accelerator
Medical Device Identifier:Linear Accelerators (1) Clinac, (2) Trilogy. Software Versions 7.x, 8.x, Serial numbers attached.
Reason of Field Safety Corrective Action:Varian states that excessive connector resistance on the above devices may cause the jaw positions to differ from the intended jaw positions without warning the operator, potentially affecting treatment.
Remedy Action:Varian is continuing to evaluate possible technical solutions for this issue. User Action (attached)
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:E9FBD38856395
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf