Z-0942-2022Class II

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

Name: Z-0942-2022 ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Creator: Varian Medical Systems Imaging Laboratory GmbH
Published: 2022-03-21
License: https://open.fda.gov/license/

Varian Medical Systems Imaging Laboratory GmbH / initiated 2022-03-21 / Completed / root cause: software

FDA source

Varian Medical Systems Imaging Laboratory GmbH began a recall of ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 on 2022-03-21. FDA classified it as Class II and gives the reason as "Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-0942-2022
Classification: Class II
Status: Completed
Initiated: 2022-03-21
Posted: 2022-04-14
Recalling firm: Varian Medical Systems Imaging Laboratory GmbH
Product: ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Product code: IYE Accelerator, Linear, Medical
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
Root cause tag: software
FDA root cause: Software Design Change
Action: On 3/21/22, Varian Medical Systems issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the recall, Varian asked consignees to take the following actions: Please retain a copy of this document along with your most current product labeling. Advise the appropriate personnel working in your radiotherapy department of the content of this letter. This document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. Please complete the attached Return Response form provided. Kindly return the completed form to [email protected].
Quantity in commerce: 14
Distribution: Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China.
Product codes and lots: DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0942-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0942-2022	Class II	Completed	Voluntary: Firm initiated	2022-04-20	2022-04-14

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)