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Open, Classified

ARTIS Pheno VE30A and VE40A, Model 10849000

FDA Recall Z-1814-2026 · Posted 2026-04-16

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-03-12
Product Quantity73

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.

Firm Action

Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S. and O.U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc. · 2024-10-22K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. · 2023-12-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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