FDA Device recall Z-0656-2021
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
- FDA Device
- Class II
- ongoing
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno by Siemens Medical Solutions Usa, citing 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 Kerm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0656-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-30 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Reason
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.
Identifiers
| code_info | Model number: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee bip…Model number: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Pheno- 10849000 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0656-2021%22
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