MOSAIQ Oncology Information System — Class II medical device recall Z-2406-2026
Ongoing recall by Elekta, Inc., reported 2026-06-17, distributed nationwide. Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occ
| Recall number | Z-2406-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-06-11 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BH, CA, CH, CN, DE, DK, ES, FR, GB, HK, IL, IN, IT, JP, LT, MT, MX, NL, PA, PK, PL, SE, TH, TR, TW |
| Quantity | 12 programs |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 07340201500071 |
Product
MOSAIQ Oncology Information System
Reason for recall
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
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-2406-2026. 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.