Siemens Medical Solutions USA, Inc: ARTIS icono ceiling. Model Number: 11328100.
Read the official notice at FDA (device) →
Get alerts for Siemens Medical Solutions
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS icono ceiling. Model Number: 11328100.
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
- Recall initiated
- 2026-06-08
- Code info
- Model Number: 11328100. UDI-DI: 4056869295923.
- Product quantity
- 57 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Malvern
- State
- PA
- Country
- United States
- Event id
- 99224
Free daily digest + "My products" watchlist