Recall archive / FDA device enforcement
ARTIS One Angiographic X-Ray System — FDA record Z-0922-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 2, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- SIEMENS MEDICAL SOLUTIONS USA, INC
- Quantity
- 1140
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0922-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number 10848600 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
23 Distributed in the US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 5, 2025
- Recall initiation date
- Jan 2, 2025
- Center classification date
- Jan 28, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.