MOSAIQ Oncology Information System with Particle Therapy License — Class II medical device recall Z-1078-2026
Ongoing recall by Elekta, Inc., reported 2026-01-21, distributed nationwide. Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Par
| Recall number | Z-1078-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2025-12-10 |
| Classified | 2026-01-13 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 07340201500026, 07340201500071 |
Product
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Reason for recall
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
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-1078-2026. 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.