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ARTIS Pheno VE30A and VE40A Imaging System
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MEDICAL DEVICE RECALLMODERATE

ARTIS Pheno VE30A and VE40A Imaging System

Siemens is recalling ARTIS Pheno VE30A and VE40A imaging systems (Model 10849000) due to unregulated dose causing unintentional low-dose radiation exposure.

What to do

Contact Siemens Medical Solutions USA, Inc. immediately to obtain a software update that regulates the medium dose during 3D acquisitions. Do not perform 3D acquisitions until the update is applied.

Posted
Updated
Recall No.
Z-1814-2026
Agency
Firm
Siemens Medical Solutions USA, Inc
Recall ID
98772
Status
ONGOING

Why it was recalled

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.

How to identify it

UPC 04056869046877

ARTIS Pheno VE30A and VE40A, Model 10849000

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Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification