Artis zee floor — Class II medical device recall Z-0469-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-11-25, distributed nationwide. Some electronic components within the generator were equipped with an incorrect protection diode. As a result,
| Recall number | Z-0469-2021 |
|---|---|
| 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 | 2020-10-21 |
| Classified | 2020-11-18 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2021-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, DE, GB, ID, IN, IT, JP, KR, PH, SA, TR, TW |
| Quantity | 26 distributed |
| Serial numbers | 109762, 111158, 111161, 124344 |
Product
Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - 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
Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
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-0469-2021. 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.