Artis Models with SW version VD12 listed below: Artis zee floor… — Class II medical device recall Z-2404-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-09-08, distributed nationwide. Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and
| Recall number | Z-2404-2021 |
|---|---|
| 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 | 2021-06-30 |
| Classified | 2021-09-02 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2023-02-10 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Serial numbers | 104005, 104007, 104012, 104013, 105500, 105501, 109645, 110001, 110005, 110006, 110007, 110014, 110016, 110017, 110018, 110022, 110023, 110024, 110025, 110026, 110027, 110031, 110032, 110035, 110036 and 45 more |
Product
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging
Reason for recall
Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
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-2404-2021. 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.