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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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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
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Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.