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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 031 10 15 000
Date submitted: 10/11/2015
Manufacturer:Varian Medical Systems
Device Type:ARIA for Radiation Oncology
Description:ARIA Oncology Information System for Radiation Oncology
Medical Device Identifier:Affected Version(s) / Lot(s): Versions 10.X, 11.X, 13.0 or 13.5 with Clinical Assessment License ONLY
Reason of Field Safety Corrective Action:Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx. When the user changes the prescription “Type” field after inputting Admin Instructions in the text box, the Admin Instructions portion of the prescription will not be saved to the database. An e-Rx transmitted to the pharmacy will not contain the intended Admin Instructions.
Remedy Action:Varian is contacting all customers potentially affected by this anomaly and will provide regular reports to listing the potentially affected prescriptions. This documentation will be provided to the customer until a verified solution has been installed.
Varian is developing a technical correction for this issue. You will be contacted by a Varian Field Service Representative when this correction is available to schedule its installation.
Athorized Representative/Importer/Distributor:Varian Medical Systems
Report Source:NCMDR
Source Ref. Number:2E413FC4AC21E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf