FDA-Device2026-07-08Class IIPROCESSING DEFECT
Siemens ARTIS icono ceiling monitor suspension recalled for loose screw risk
What this means
Siemens has identified a potential issue with the Display ceiling suspension (DCS Fix XL) component on ARTIS icono ceiling systems. Over time, screws that secure the monitor to the suspension may gradually loosen, which could affect the stability of the mounted display.
- If you operate an ARTIS icono ceiling system (Model 11328100), contact Siemens Medical Solutions for inspection and corrective service.
- Do not attempt to adjust or tighten screws yourself without guidance from the manufacturer.
- Continue normal use while awaiting service, but monitor the display for any visible movement or shifting.
The agency's original wording
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
Affected count
57 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS icono ceiling. Model Number: 11328100.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2648-2026More Siemens recalls
- FDA-Device2026-07-08Siemens ARTIS icono ceiling model 11328100 recalled for loss of movement capability
- FDA-Device2026-07-08Siemens ARTIS icono biplane recalled for potential loss of movement after detector adjustment
- FDA-Device2026-07-08Siemens ARTIS icono floor recalled for potential movement loss at detector height limits
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