Artis zee Biplane — Class II medical device recall Z-1497-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-03-25, distributed nationwide. A software issue could potentially cause the stand and table movements to be blocked.
| Recall number | Z-1497-2020 |
|---|---|
| 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 | 2020-02-14 |
| Classified | 2020-03-13 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2021-04-20 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Serial numbers | 124286, 125001, 125201, 125208, 125210, 125213, 125214, 125222, 125223, 125227, 125228, 125229, 125232, 125233, 125238, 125239, 125240, 125241, 125244, 125245, 125249, 126202, 131219, 131221, 131223 and 257 more |
| Model numbers | 10094135, 10094137, 10094141, 10280959 |
Product
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for recall
A software issue could potentially cause the stand and table movements to be blocked.
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-1497-2020. 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.