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