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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 015 10 11 000
Date submitted: 10/8/2011
Manufacturer:Varian Medical Systems
Device Type:Accelerator System, Linear, True Beam
Description:Accelerator System, Linear,
Medical Device Identifier:True Beam 1.0
Reason of Field Safety Corrective Action:This letter is to advise you of an anomaly that has been identified with the imaging arms of the True Beam accelerator where loose encoder pulleys could lead to inaccurate readout of arm geometry.
Remedy Action:check the geometric accuracy of the imaging system using a geometric Q/A phantom. Varian is developing a plan to inspect/replace the wrist encoder readout systems to ensure that there are no assembly problems.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:BD2205DCB3273
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf