Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
US Nationwide distribution including in the states of CA, MI and MN.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2021