Siemens Medical Solutions Usa, Inc: Interventional Fluoroscopic X-ray System
Recall Summary Siemens Medical Solutions is recalling ARTIS icono ceiling X-ray systems (Model 11328100) because screws in the Display ceiling suspension that holds the monitor in place may gradually loosen over time. This Class II recall affects systems distributed nationwide to healthcare facilities in multiple states. The potential loosening of these screws could cause the monitor to become unstable.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS icono ceiling. Model Number: 11328100.
- Reason
- Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/224255e1-7899-4807-9341-5a1c2b1d793a