FDA Device recall Z-0997-2013
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0997-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-08 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Reason
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.
Identifiers
| code_info | Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0997-2013%22
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