Z-2205-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- March 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
Product Description
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Reason for Recall
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Distribution Pattern
US and Worldwide
Code Information
UDI: 4056869046877