FDA Device recall Z-0922-2025
ARTIS One Angiographic X-Ray System
- FDA Device
- Class II
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class II recall of ARTIS One Angiographic X-Ray System by Siemens Medical Solutions Usa, citing A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper pre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0922-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-02 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
ARTIS One Angiographic X-Ray System
Reason
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Identifiers
| code_info | Model Number 10848600 |
|---|
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-0922-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.