Artis Q — Class II medical device recall Z-0304-2022
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-12-01, distributed nationwide. If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray
| Recall number | Z-0304-2022 |
|---|---|
| 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 | 2021-10-20 |
| Classified | 2021-11-24 |
| Reported by FDA | 2021-12-01 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Serial numbers | 111133, 111500, 111501, 111502, 111503, 111504, 111505, 111506, 111507, 111508, 111510, 111512, 111513, 111514 |
| Model numbers | 10848354 |
Product
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Reason for recall
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
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-0304-2022. 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.