Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 091 11 11 000
Varian Medical Systems
Radiation Therapy, Eclipse with ARIA™ Radiation Oncology (RT Chart module)
Radiation Therapy, treatment planning system
Medical Device Identifier:
Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34). Serial numbers list attached.
Reason of Field Safety Corrective Action:
An anomaly has been identified within Varian Eclipse™ when used with ARIA™ Radiation Oncology (RT Chart module) where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse.
Varian will be notifying all affected customers with a letter. This issue has been corrected in a maintenance release (10MR2, Client Build 10.0.39) of Eclipse and ARIA RT Chart. All affected customers will be contacted by Varian to schedule installation.
Varian Medical Systems, Riyadh, (01) 2772126
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Varian Medical Systems.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.