ARTISTE MV System — Class II medical device recall Z-1212-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-02-22. Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical pr
| Recall number | Z-1212-2017 |
|---|---|
| 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 | 2017-01-25 |
| Classified | 2017-02-15 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2018-10-01 |
| Quantity | 194 systems |
| Serial numbers | 3103, 3114, 3136, 3225, 3241, 3244, 3267, 3274, 3296, 3302, 3305, 3354, 3361, 3367, 3383, 3397, 3413, 3422, 3479, 3504, 3515, 3519, 3541, 3547, 3565 and 169 more |
| Model numbers | 8139789 |
Product
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason for recall
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
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-1212-2017. 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.