Z-1814-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2026
- Initiation Date
- March 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 73
Product Description
ARTIS Pheno VE30A and VE40A, Model 10849000
Reason for Recall
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.
Distribution Pattern
U.S. and O.U.S.
Code Information
UDI 04056869046877