Critical RiskFDA Device

O-Two Medical Technologies, Inc.: 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.

Agency Publication Date: April 4, 2019

Affected Products

Product: e500 Automatic Transport Ventilator, Model Number 01EVE500

EV50001 to EV50148

Product: e600 Automatic Transport Ventilator, Model Number 01EVE600

EV60001 to EV60126

Product: e700 Automatic Transport Ventilator, Model Number 01EVE700

EV70001 to EV70658

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82178

Status: Resolved

Manufacturer: O-Two Medical Technologies, Inc.

Manufactured In: Canada

Units Affected: 3 products (136; 119; 632)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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