CLASS II ONGOING Device recall · Reported 22 Apr 2026 · FDA Enforcement Report

Artis Pheno VE30A and VE40A recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artis Pheno VE30A and VE40A. The recall was initiated on 12 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 04056869046877

Quantity recalled73

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1814-2026
FDA event ID: 98772
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Mar 2026
FDA classified: 16 Apr 2026
Reported: 22 Apr 2026
Type: FDA Mandated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Mar 2026	Recall initiated by company
16 Apr 2026	Classified by FDA	+35 days
22 Apr 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

ARTIS Pheno VE30A and VE40A, Model 10849000

Where it was distributed

U.S. and O.U.S.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI 04056869046877

Where was it sold?

U.S. and O.U.S.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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