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Recall Observatory FDA recall evidence

Device product

ARTIS Pheno VE30A and VE40A, Model 10849000

Z-1814-2026

March 12, 2026

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 98772
Status
Ongoing
Classification
Class II
Quantity
73
Official record key
device-enforcement:Z-1814-2026

Official wording

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.

Code information: UDI 04056869046877

Distribution pattern: U.S. and O.U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.