Siemens Medical Solutions Usa, Inc: Interventional Fluoroscopic X-ray System
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-09
- Status
- Open, Classified
- Distribution
- US and Worldwide
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7ffa9890-f6e3-423d-b198-d52641d6c615