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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 065 08 11 000
Date submitted: 8/22/2011
Manufacturer:Varian Medical Systems
Device Type:Eclipse treatment planning system
Description:Information Systems, Data Management, Oncology, Radiotherapy
Medical Device Identifier:Eclipse treatment planning system client software versions 8.0 through 8.6. See attachment for serial numbers
Reason of Field Safety Corrective Action:Anomaly in Eclipse versions 8.0 to 8.6 whereby a particular plan approval workflow may result in a difference between the intended SSD value and the SSD value communicated to the treatment delivery system.
Remedy Action: Varian is notifying all possibly affected customers with this document.  Varian is instructing users of affected systems on adequate remedial actions via this document.  The product behavior has been mitigated in version 8.9
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh (01) 2772126
Report Source:NCMDR
Source Ref. Number:637E7F9DDA2D7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Eclipse.pdf