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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 017 09 12 000
Date submitted: 9/2/2012
Manufacturer:Varian Medical Systems
Device Type:Eclipse™ Treatment Planning System
Description:Treatment Planning System
Medical Device Identifier:Eclipse 8.9 and 10.0
Reason of Field Safety Corrective Action: An outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server.
Remedy Action: For each Eclipse client workstation, ensure that the workstation clock is synchronized with the Database/System server clock. Contact Varian service for assistance with time synchronization if required. As recommended in the Eclipse Instructions for Use, always verify the dose calculation using independent verification methods to ensure the MU calculation is correct. Varian medical system is devloping a techincal correction for this issue. Varian Customer Support Services will contact customers when the correction is available to schedule its installion on you system.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:50DB1E368A209
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf