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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 048 12 11 000
Date submitted:
12/11/2011
Manufacturer:
Varian Medical Systems
Device Type:
Radiation Therapy, Treatment Planning System. 4D Structure Merge Tool Option in Eclipse
Description:
Radiation Therapy, Treatment Planning System
Medical Device Identifier:
4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (client build 8.2.2x through 10.0.34) with 4D Planning.
Reason of Field Safety Corrective Action:
Combining use of the 4D Structure Merge Tool Option with Couch Structure Insertion in Eclipse may result in the displacement of patient structures.
Remedy Action:
Varian is notifying affected customers. And they will be contacted by Varian when the correction is available.
Athorized Representative/Importer/Distributor:
Varian Medical Systems, Riyadh, (01) 2772126
Report Source:
NCMDR
Source Ref. Number:
5BAFB2B0B9325
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Varian Medical Systems.pdf
View History
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.