Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA… — Class II medical device recall Z-0997-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-04-03, distributed nationwide. The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that
| Recall number | Z-0997-2013 |
|---|---|
| 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 | 2013-03-08 |
| Classified | 2013-03-26 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2014-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 81 |
| Reason classes | software |
| Model numbers | 10094135, 10094137, 10094139, 10094141, 10280959 |
Product
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Reason for recall
The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.
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-0997-2013. 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.