interventional fluoroscopic x-ray system
- Recall Initiated
- May 15, 2025
- Posted
- June 27, 2025
- Recall Number
- Z-2020-2025
- Firm Location
- Malvern, PA
Reason for Recall
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.
Distribution
Worldwide.
Lot / Code Info
4056869063317
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.