Artis zee/ zeego & Artis Q/ Q — Class II medical device recall Z-0656-2021
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2021-01-20, distributed nationwide. When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during
| Recall number | Z-0656-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2020-11-30 |
| Classified | 2021-01-11 |
| Reported by FDA | 2021-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 5,602 |
Product
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Reason for recall
When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.
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-0656-2021. 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.