Siemens Medical Solutions Usa, Inc: Interventional Fluoroscopic X-ray System
Recall Summary Siemens Medical Solutions is recalling the ARTIS icono biplane X-ray system (Model 11327600) distributed nationwide because the detector lift mechanism may lose movement capability when adjusted to its highest or lowest positions. This Class II recall affects medical facilities across all U.S. states and the District of Columbia that operate this interventional fluoroscopic imaging equipment.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS icono biplane. Model Number: 11327600.
- Reason
- Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/48a9c955-ad31-49b8-8b5a-6577cf825949