FDA-Device2023-12-20Class II
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Siemens Medical Solutions USA, Inc
Hazard
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
Sold states
US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
Affected count
38 worldwide, 11 US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2024Don't want to check this manually?
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