FDA-Device2026-07-08Class II
ARTIS icono ceiling. Model Number: 11328100.
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.
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 Medical Solutions USA, Inc recalls
- FDA-Device2026-07-08ARTIS icono floor. Model Number: 11327700.
- FDA-Device2026-07-08ARTIS icono biplane. Model Number: 11327600.
- FDA-Device2026-07-08ARTIS icono ceiling. Model Number: 11328100.
- FDA-Device2026-04-22Siemens ARTIS Pheno VE30A and VE40A imaging system recalled for potential unintended radiation exposure
- FDA-Device2026-04-15Siemens ARTIS pheno and ARTIS Icono biplane systems recalled for inaccurate x-ray dose display
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