Recall Z-0170-2016— Varian Medical Systems, Inc.

Name: FDA recall Z-0170-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-28

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2015-09-28, terminated 2017-05-12. It names one FDA 510(k) clearance: K093527. Product: ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.. Reason: An anomaly was 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..

Recalling firm: Varian Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-09-28
Terminated: 2017-05-12
Firm location: Palo Alto, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K093527 — ARIA RADIATION ONCOLOGY WITH MIRSVarian Medical Systems, Inc.·cleared 2009-12-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.

Reason for recall

An anomaly was 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.