Z-1653-2026Class II

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700

Name: Z-1653-2026 ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700
Creator: Siemens Medical Solutions USA, Inc
Published: 2026-03-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2026-03-10 / Open, Classified

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700 on 2026-03-10. FDA classified it as Class II and gives the reason as "During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1653-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-10
Posted: 2026-04-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
FDA root cause: Radiation Control for Health and Safety Act
Action: Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice, dated March 9, 2026, to all affected customers.
Quantity in commerce: U.S. 758, OUS 2077
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1653-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1653-2026	Class II	Ongoing	FDA Mandated	2026-04-15	2026-04-07

Product code OWB

K241572Class IIARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc. / cleared 2024-10-22

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)