FDA Device recall Z-0942-2022
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
- FDA Device
- Class II
- completed
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 by Varian Medical Systems Imaging Laboratory, citing software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0942-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-03-21 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Varian Medical Systems Imaging Laboratory |
| Distribution | US |
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
Identifiers
| code_info | DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0942-2022%22
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