PRIMUS — Class II medical device recall Z-2877-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-10-05, distributed nationwide. Software patch installation to address several safety issues.
| Recall number | Z-2877-2016 |
|---|---|
| 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 | 2016-07-26 |
| Classified | 2016-09-23 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2018-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 103 accelerators |
| Reason classes | software |
| Serial numbers | 10002, 10004, 10005, 10007, 10008, 10010, 10013, 10015, 10019, 10021, 10022, 10023, 10024, 10025, 10035, 10039, 10045, 10046, 10047, 10050, 10063, 10074, 10096, 10105, 10501 and 77 more |
| Model numbers | 08162815, 8168754 |
Product
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Reason for recall
Software patch installation to address several safety issues.
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-2877-2016. 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.