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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 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