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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 016 06 12 000
Date submitted: 6/4/2012
Manufacturer:Varian Medical Systems
Device Type:Accelerator System, TrueBeam
Description:Accelerator System, linear, prone patients
Medical Device Identifier:1.0, and below, and below Serial number attached
Reason of Field Safety Corrective Action:A software anomaly has been identified in TrueBeam when using respiratory gating with patients treated in the prone position. The anomaly is the respiratory gating curve is inverted when a prone patient plan is loaded into TrueBeam.
Remedy Action:Notification to customer through a Field Safety Notice. A software correction will be provided to current customers to mitigate the anomaly.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:3E6583DE1721B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf