FDAClass II · Medical device · Recalled June 10, 2026

ARTIS Icono biplane recall — Siemens Medical Solutions USA, Inc

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2206-2026
Brand: Siemens Medical Solutions USA
Classification: Class II
Recall status: Ongoing
Initiated: FDA Mandated

Description

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

Affected products

ARTIS Icono biplane

Companies & origin

Recalling firm location: Malvern, PA, United States
Firm address: 40 Liberty Blvd, 19355-1418

Identifying details (verbatim from the notice)

Product codes / lots: ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325
Distribution: US and Worldwide
FDA event ID: 98992
Recall initiated: March 9, 2026
FDA classified: June 4, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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