Artis zee — Class II medical device recall Z-1824-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-04-26, distributed in CA, VA, WI. Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 g
| Recall number | Z-1824-2017 |
|---|---|
| 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 | 2017-03-28 |
| Classified | 2017-04-14 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2017-08-07 |
| Distributed | CA, VA, WI |
| Quantity | 3 units |
| Reason classes | software |
| Serial numbers | 147208, 153744, 160449 |
| Model numbers | 10094137, 10094141, 10280959 |
Product
Artis zee, Angiographic x-ray system
Reason for recall
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
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-1824-2017. 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.