FDASeptember 11, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
What to do
FDA enforcement status: Ongoing
Brands named
bien air surgery sabienbien air
Recall history
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