medical Class II Updated 2023-12-20

Siemens Medical Solutions USA, Inc recalls ARTIS icono (ceiling configuration), Fluoroscopic x-ray syst

Recalled Product

ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →