FDA recall Z-1814-2026

Product

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

U.S. and O.U.S.

Key facts

Status

Ongoing

Initiation date

2026-03-12

Report date

2026-04-22

Voluntary/Mandated

FDA Mandated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1814-2026