Recall Z-0942-2022— Varian Medical Systems Imaging Laboratory GmbH

Name: FDA recall Z-0942-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-21

Class II · Completed

Class II FDA medical device recall by Varian Medical Systems Imaging Laboratory GmbH, initiated 2022-03-21. It names 2 FDA 510(k) clearances: K173838, K133572. Product: ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1. Reason: Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location.

Recalling firm: Varian Medical Systems Imaging Laboratory GmbH
Classification: Class II
Status: Completed
Initiated: 2022-03-21
Firm location: Baden, N/A, Switzerland

510(k) clearances named in this recall

2 on FDA's record

K173838 — ARIA Radiation Therapy ManagementVarian Medical Systems, Inc.·cleared 2018-01-17
K133572 — ARIA RADIATION THERAPY MANAGEMENTVarian Medical Systems, Inc.·cleared 2014-04-04

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 Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

Reason for recall

Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

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