ARIA Radiation Therapy Management — Class II medical device recall Z-0942-2022
Completed recall by Varian Medical Systems Imaging Laboratory GmbH, reported 2022-04-20, distributed nationwide. Software issue for treatment plan and image management application may result in mismatch values which could r
| Recall number | Z-0942-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems Imaging Laboratory GmbH, Baden, N/A, Switzerland |
| Recall initiated | 2022-03-21 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, KR, NL, PL |
| Quantity | 14 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127, 00856100006165 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0942-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.