FDA Enforcement
Class II
Ongoing
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Recall: Z-2206-2026
·
Reported June 10, 2026
Enforcement
- Recall Number
- Z-2206-2026
- 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 Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. 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
ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325
Distribution
US and Worldwide