Recall archive / FDA device enforcement
ARTIS Pheno VE30A and VE40A, Model 10849000 — FDA record Z-1814-2026
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 12, 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 VE30A and VE40A, Model 10849000
- Reason
- During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 73
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1814-2026
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 04056869046877 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. and O.U.S.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 22, 2026
- Recall initiation date
- Mar 12, 2026
- Center classification date
- Apr 16, 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.