Recall archive / FDA device enforcement
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system — FDA record Z-2205-2026
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 Mar 9, 2026. 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 pheno, Model 10849000. interventional fluoroscopic x-ray system
- Reason
- During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2205-2026
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 | UDI: 4056869046877 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US and Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 10, 2026
- Recall initiation date
- Mar 9, 2026
- Center classification date
- Jun 4, 2026
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.