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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 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