ARTISTE MV System — Class II medical device recall Z-0984-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-03-25, distributed in NY, UT, WI. There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments
| Recall number | Z-0984-2015 |
|---|---|
| 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 | 2014-11-19 |
| Classified | 2015-03-18 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-04-28 |
| Distributed | NY, UT, WI |
| Quantity | 3 |
| Reason classes | software |
| Serial numbers | 5419, 5784, 5830 |
| Model numbers | 08139789 |
Product
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason for recall
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
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-0984-2015. 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.