—#219414

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K241572
Affected lot / code info: ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice, dated March 9, 2026, to all affected customers.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Worldwide - US Nationwide distribution.

Timeline

Recall initiated: 2026-03-10
Posted by FDA: 2026-04-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #219414. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.