Brilliance CT Big Bore System-Main Unit, Brilliance ICT System — recall 58071
Health Canada — Medical Devices · Canada · 2018-03-13 · Type II
As described by Health Canada — Medical Devices: Brilliance CT Big Bore System-Main Unit, Brilliance ICT System - System, Brilliance ICT SP System - Main and Ingenuity CT System (2018-02-14)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: Upon closing the Emergency Stop (E-STOP) the system performs an internal check. As a result of the motion controller in the couch, there is a delay in the response to the internal check. This delay may cause the couch carbon top to enter a free float state, which may allow it to move during patient load or unload activities. This free float motion results in the ESTOP being opened due to the unexpected couch motion. This issue occurs frequently after closing E-STOP. The motion controller in the couch detects a power problem and disables the horizontal motor, which allows the couch top to free-float*. *The term free float refers to the couch top being in a state that is not locked in position by the brake or being moved in a controlled fashion manual or automatic motion.
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