ARTISTE with syngo RT Therapist-linear accelerator systems to deliver… — Class II medical device recall Z-0441-2022
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2022-01-05, distributed nationwide. Potential safety issue under specific preconditons that may result in a user selecting the wrong site for trea
| Recall number | Z-0441-2022 |
|---|---|
| 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 | 2021-12-09 |
| Classified | 2021-12-29 |
| Reported by FDA | 2022-01-05 |
| Terminated | 2023-05-04 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| Serial numbers | 10085, 10524, 10586, 10736, 10737, 10792, 10793, 10822, 10843, 10850, 10865, 10886, 11122 |
| Model numbers | 8162815 |
Product
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Reason for recall
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
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-0441-2022. 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.