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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 036 01 19 000
Date submitted: 1/14/2019
Manufacturer:Varian Medical Systems
Device Type:ARIA Oncology Information System for Radiation Oncology
Description:Radiation Oncology
Medical Device Identifier:Affected Version(s) / Lot(s): 15.1, 15.5, 15.6
Reason of Field Safety Corrective Action:Varian Medical Systems has identified a problem in ARIA Oncology Information System (OIS) for Radiation Oncology such that a user may inadvertently chart medical record information in an unintended patient’s chart.
Remedy Action:-Varian recommends that Users close each patient prior to opening a new one. This will prevent this issue from occurring.

-Varian Medical Systems is investigating this issue. The timeline of a technical solution is currently unknown. Varian will contact users as a fix is available.
Athorized Representative/Importer/Distributor:Varian Medical Systems Arabia Commercial Limited
Report Source:NCMDR
Source Ref. Number:138B3678601AC
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf