Official recall notice
FDA Recall: ARTIS Pheno VE30A and VE40A, Model 10849000
- Recall date
- 2026-04-22
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
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Product description
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.