LINAC Accelerators: ARTISTE — Class II medical device recall Z-1059-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-02-11, distributed nationwide. A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a r
| Recall number | Z-1059-2015 |
|---|---|
| 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 | 2014-12-19 |
| Classified | 2015-02-05 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2017-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 310 |
| Reason classes | device malfunction |
| Serial numbers | 2045, 2067, 2125, 2183, 2228, 2244, 2507, 2516, 2527, 2532, 2586, 2596, 2628, 2644, 2646, 2689, 2702, 2814, 2818, 2827, 2834, 2845, 2855, 2863, 2887 and 285 more |
| Model numbers | 01924500, 01940035, 01940753, 04504200, 05500371, 05857912, 05857920, 05863472, 07360717, 08139789, 08515520, 09401316, 09401407, 09401506, 09401654, 09401746, 09411588, 09822685, 09822693 |
Product
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Product Usage: The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason for recall
A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission.
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-1059-2015. 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.