ELEKTA MOSAIQ SW version below 2 — Class II medical device recall Z-1077-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-04-17. A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufactur
| Recall number | Z-1077-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Martinez, CA, United States |
| Recall initiated | 2012-12-20 |
| Classified | 2013-04-09 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2013-07-19 |
| Quantity | 101 |
Product
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Reason for recall
A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.
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-1077-2013. 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.