FDA-Device2020-10-28Class II
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.
Bien-Air Surgery Sa
Hazard
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Sold states
US Nationwide distribution including in the states of CA, MI and MN.
Affected count
Total US = 1120 foot pedals
Manufactured in
rue de l' ouest 2b, N/A, Le Noirmont, N/A, Switzerland
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2021Don't want to check this manually?
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