FDA recall Z-0976-2019

O-Two Medical Technologies, Inc. · Class I · device

Product

e500 Automatic Transport Ventilator, Model Number 01EVE500

Reason for recall

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.

Distribution

The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.

Key facts

Status: Terminated
Initiation date: 2019-02-12
Report date: 2019-04-10
Termination date: 2023-06-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brampton, Ontario, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0976-2019