MOSAIQ Oncology Information System — Class II medical device recall Z-1162-2025
Ongoing recall by Elekta, Inc., reported 2025-02-19, distributed in AL, FL, IA, PA, UT. Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINA
| Recall number | Z-1162-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2025-01-15 |
| Classified | 2025-02-11 |
| Reported by FDA | 2025-02-19 |
| Distributed | AL, FL, IA, PA, UT |
| Countries outside the US | AT, BE, BO, BR, CA, DE, ES, FR, HK, IT, JP, KR, MT, NL, PA, TH, TR, TW, VE, ZA |
| Quantity | 64 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07340201500026, 07340201500071 |
Product
MOSAIQ Oncology Information System
Reason for recall
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
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-1162-2025. 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.