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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 016 06 12 000
Varian Medical Systems
Accelerator System, TrueBeam
Accelerator System, linear, prone patients
Medical Device Identifier:
1.0, 18.104.22.168 and below, 22.214.171.124 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.
Notification to customer through a Field Safety Notice. A software correction will be provided to current customers to mitigate the anomaly.
Varian Medical Systems, Riyadh, (01) 2772126
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Varian Medical Systems.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.