Siemens Medical Solutions USA, Inc Recall 87026
Description: Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Siemens Medical Solutions USA, Inc Recall 87026 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0656-2021 |
| Event ID | 87026 |
| Event Description | Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno |
| Product Type | Devices |
| Distribution | Worldwide-US Nationwide |
| Quantity | 5602 |
| Recall 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. |
| Device Classification | 20210120 |
| Device Code Info | 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 |
| Center Classification Date | 20210111 |
| Recall Initiation Date | 20201130 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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