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Open, Classified

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

FDA Recall Z-2205-2026 · Posted 2026-06-04

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-03-09

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.

Firm Action

Distribution of Customer Advisory Notice (CAN) to all affected customers began by Siemens on March 9, 2026.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US and Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc. · 2024-10-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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