Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system |
| Quantity | 81 |
| Distribution | Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico. |
| Initiated | 2013-03-08 |
| Classified | 2013-03-26 |
| Terminated | 2014-11-06 |
| Recall number | Z-0997-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-0997-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64662/
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