E600 Automatic Transport Ventilator recalled over fire hazard

Recall date

February 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

O-Two Medical Technologies, Inc. recalls e600 Automatic Transport Ventilator, Model Number 01EVE600

Recall number

Z-0977-2019

FDA classification

Class I

Brand / firm

O-Two Medical Technologies, Inc.

Sold / distributed

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

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

e600 Automatic Transport Ventilator, Model Number 01EVE600