Z-1653-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2026
- Initiation Date
- March 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- U.S. 758, OUS 2077
Product Description
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Reason for Recall
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.