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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 049 02 11 000
Varian Medical Systems
RT Chart, ARIA Information System
Radiotherapy, planning, simulators: computer treatment planning
Medical Device Identifier:
RT Chart, a function of ARIA versions 8.0 and 8.1. Refer to tha attached list for serial numbers
Reason of Field Safety Corrective Action:
When an image sequence template is added to a field in RT Chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect.
1. Varian is notifying potentially affected users by way of this Urgent Field Safety Notice. 2. Varian has made design changes to address this issue in ARIA Radiation versions 8.2 and later. A corrective action will be undertaken to upgrade all affected systems to an unaffected later version of the software. If this has not already been done on your system, you will be contacted to schedule the update on your system.
Varian Medical Systems, Riyadh (01) 2772126
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.