FDA Device recall Z-2529-2025
Artis Pheno
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Artis Pheno by Siemens Medical Solutions Usa, citing limited system movements after startup .
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2529-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-12 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Reason
Limited system movements after startup .
Identifiers
| code_info | Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164…Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2529-2025%22
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