Z-1814-2026Class II

ARTIS Pheno VE30A and VE40A, Model 10849000

Name: Z-1814-2026 ARTIS Pheno VE30A and VE40A, Model 10849000
Creator: Siemens Medical Solutions USA, Inc
Published: 2026-03-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2026-03-12 / Open, Classified

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Pheno VE30A and VE40A, Model 10849000 on 2026-03-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1814-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-12
Posted: 2026-04-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Pheno VE30A and VE40A, Model 10849000
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers dated March 9, 2026.
Quantity in commerce: 73
Distribution: U.S. and O.U.S.
Product codes and lots: UDI 04056869046877

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1814-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1814-2026	Class II	Ongoing	FDA Mandated	2026-04-22	2026-04-16

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)