MOSAIQ Oncology Information System — Class II medical device recall Z-2591-2021
Ongoing recall by Elekta, Inc., reported 2021-10-06, distributed in CA, CO, FL, ID, LA, MO, MS, NC…. A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength
| Recall number | Z-2591-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2021-09-02 |
| Classified | 2021-09-29 |
| Reported by FDA | 2021-10-06 |
| Distributed | CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, WA |
| Countries outside the US | AU, CA, GB |
| Quantity | 31 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00858164002367 |
Product
MOSAIQ Oncology Information System
Reason for recall
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
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-2591-2021. 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.