—#214632

Product

interventional fluoroscopic x-ray system

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K241572
Affected lot / code info: 4056869295923

Why it was recalled

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Siemens Healthineers sent customers a Customer Advisory Notice dated May 15, 2025 informing customers of a potential issue with ARTIS pheno and ARTIS icono systems with the following model numbers: ARTIS pheno 10849000, ARTIS icono biplane 11327600, ARTIS icono ceiling 11328100, ARTIS icono floor 11327700; due to in very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose and appropriate software update will be implemented, based on the current software version of the affected system.

Recalling firm

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

Distribution

Distribution pattern: Worldwide.

Timeline

Recall initiated: 2025-05-15
Posted by FDA: 2025-06-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214632. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.