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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 049 02 11 000
Date submitted: 2/21/2011
Manufacturer:Varian Medical Systems
Device Type:RT Chart, ARIA Information System
Description: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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh (01) 2772126
Report Source:NCMDR
Source Ref. Number:E7E4B94869335
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: CP-03103_FSN_rev_B-ENG[1].pdf