FDA Medical Device Recalls (openFDA)
Varian Medical Systems Imaging Laboratory GmbH: ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
- Recall number
- Z-0942-2022
- 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
- Status
- Completed
- Initiated
- 2022-03-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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 returnresponse@varian.com.
- Quantity
- 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.
- Lot, serial or model codes
- DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165
- 510(k) numbers
- ["K133572","K173838"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3003094912
- Firm city
- DATTWIL Baden
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28