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NCMDR Recall
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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, 1.5.12.0 and below, 1.6.9.5 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
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Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.