Syngo RT Therapist — Class II medical device recall Z-2878-2016
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-2878-2016 |
|---|---|
| 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
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording
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-2878-2016. 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.