Z-2206-2026Class II

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model...

Name: Z-2206-2026 ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model...
Creator: Siemens Medical Solutions USA, Inc
Published: 2026-03-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2026-03-09 / Open, Classified

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700... on 2026-03-09. FDA classified it as Class II and gives the reason as "During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2206-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-09
Posted: 2026-06-04
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
FDA root cause: Radiation Control for Health and Safety Act
Action: Distribution of Customer Advisory Notice (CAN) to all affected customers began by Siemens on March 9, 2026.
Distribution: US and Worldwide
Product codes and lots: 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-2206-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2205-2026	Class II	Ongoing	FDA Mandated	2026-06-10	2026-06-04
Z-2206-2026	Class II	Ongoing	FDA Mandated	2026-06-10	2026-06-04

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)