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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 028 07 11 000
Date submitted:
7/9/2011
Manufacturer:
Varian Medical Systems
Device Type:
Treatment planning system, Eclipse
Description:
Radiation Therapy
Medical Device Identifier:
Eclipse Release 6.5 through 10 (build 7.3.10 through 10.0.34)
Reason of Field Safety Corrective Action:
In affected Eclipse versions, user editing of MLC leaf positions may not automatically invalidate calculated dose distributions.
Remedy Action:
Varian is preparing a maintenance release (service pack) of Eclipse software to address this issue. You will be contacted by a Varian representative to schedule installation of a corrected version once available.
Athorized Representative/Importer/Distributor:
Varian Medical Systems, Riyadh, (01) 2772126
Report Source:
NCMDR
Source Ref. Number:
AD9DDB80042A9
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Varian Medical Systems - FSN.pdf
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Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.