Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system

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.

interventional fluoroscopic x-ray system

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.

• FDA enforcement recordOfficial FDA database entry for Z-2021-2025
• FDA 510(k) clearance · K241572The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Medical Solutions USA, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.