ARIA Radiation Oncology — Class II medical device recall Z-0187-2013
Terminated recall by Varian Medical Systems, Inc. Oncology Systems, reported 2012-11-07, distributed nationwide. An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one
| Recall number | Z-0187-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, United States |
| Recall initiated | 2012-09-24 |
| Classified | 2012-11-01 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DK, GB |
| Quantity | 205 |
| Serial numbers | H1T0339R1, H1T1523R1, H1T2425, HIT0027, HIT0028, HIT0032, HIT0134, HIT0155, HIT0170M, HIT0170R1, HIT0170R2, HIT0170R3, HIT0182, HIT0183, HIT0191M, HIT0191R1, HIT0191R2, HIT0227, HIT0339M, HIT0342, HIT0397, HIT0432M, HIT0432R1, HIT0432R2, HIT0468M and 130 more |
Product
ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
Reason for recall
An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
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-0187-2013. 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.