MEVATRON M2 / PRIMUS Mid-Energy — Class II medical device recall Z-1397-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-04-25, distributed nationwide. Control Console software has been updated to reduce the risk for collision when delivering automatically seque
| Recall number | Z-1397-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2018-02-14 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2019-05-16 |
| Distributed | Nationwide (US) |
| Quantity | 18 |
| Reason classes | software |
| Serial numbers | 2855, 3103, 3136, 3274, 3296, 3383, 3591, 3618, 3629, 3639, 3644, 3939, 3986, 4018, 5092, 5474, 70-4323, 70-4347 |
| Model numbers | 01940035 |
Product
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason for recall
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
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-1397-2018. 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.