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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00988-1
Product Name/Description ARIA for Radiation Oncology and ARIA Oncology Information System for Radiation Oncology, Versions10.X, 11.X, 13.0 or 13.5 with Clinical Assessment licence only

Serial Numbers: HIT0739M, HIT0968, HIT1044, HIT1172M, HIT1390, HIT1421, HIT1599M, HIT1649, HIT2083, HIT2129M, HIT2263M, HIT2535, HIT2620, HIT2724, HIT3692, HIT3700, HIT4526M, HIT4909

ARTG Number: 132638
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/10/2015
Responsible Entity Varian Medical Systems Australasia Pty Ltd
Reason/Issue An anomaly that has been identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. 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. The printed prescription will also not contain the intended Admin Instructions. There have not been any reports of patient injury due to this issue.
Recall Action Recall for Product Correction
Recall Action Instructions Varian is contacting all customers potentially affected by this anomaly with the temporary workaround 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. Customers will be contacted by a Varian Field Service Representative when this correction is available to schedule its installation.

This action has been closed out on the 12/10/2018.
Contact Information 02 9485 0100 - Varian