Interventional X-Ray System (Siemens) – Dose Sensor Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
interventional fluoroscopic x-ray system
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
4056869063317
Products Sold
4056869063317
Siemens Medical Solutions USA, Inc is recalling interventional fluoroscopic x-ray system 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026