FDA Enforcement
Class II
Ongoing
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Recall: Z-2205-2026
·
Reported June 10, 2026
Enforcement
- Recall Number
- Z-2205-2026
- Event ID
- 98992
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- FDA Mandated
- Report Date
- June 10, 2026
- Initiation Date
- March 9, 2026
- Classification Date
- June 4, 2026
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
Description
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Reason
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.
Code Info
UDI: 4056869046877
Distribution
US and Worldwide