FDA-Device2019-04-10Class I
e600 Automatic Transport Ventilator, Model Number 01EVE600
O-Two Medical Technologies, Inc.
Hazard
There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.
Sold states
The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
Affected count
119
Manufactured in
45A Armthorpe Road, N/A, Brampton, Ontario, Canada
Products
e600 Automatic Transport Ventilator, Model Number 01EVE600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0977-2019Don't want to check this manually?
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