Recall Z-0552-2014— Varian Medical Systems, Inc.

Name: FDA recall Z-0552-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-18

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2013-11-18, terminated 2015-03-13. It names 2 FDA 510(k) clearances: K131807, K093527. Product: Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.. Reason: An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change..

Recalling firm: Varian Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-18
Terminated: 2015-03-13
Firm location: Palo Alto, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K131807 — HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems, Inc.·cleared 2013-10-11
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

Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.

Reason for recall

An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.

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