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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 023 09 11 000
Date submitted: 9/5/2011
Manufacturer:Varian Medical Systems
Device Type:Eclipse Treatment Planning System
Description:Radiation Therapy, treatment planning system
Medical Device Identifier:Eclipse 10 (Client builds 10.0.28 and 10.0.34). Serial numbers attached.
Reason of Field Safety Corrective Action:The treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the MU or calculated dose distribution.
Remedy Action:A Varian representative will contact affected customers to apply a database configuration script.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:C1757618DF2A3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems - FSN.pdf