Recall Z-0187-2013— Varian Medical Systems, Inc. Oncology Systems

Name: FDA recall Z-0187-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-24

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2012-09-24, terminated 2013-12-05. It names one FDA 510(k) clearance: K093527. Product: ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.. Reason: An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued..

Recalling firm: Varian Medical Systems, Inc. Oncology Systems
Classification: Class II
Status: Terminated
Initiated: 2012-09-24
Terminated: 2013-12-05
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, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.

Reason for recall

An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.

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