BEUDAMED
    FDA Recall Terminated

    e500 Automatic Transport Ventilator, Model Number 01EVE500

    Recall: Z-0976-2019 · Initiated February 12, 2019

    Recall

    Recall Number
    Z-0976-2019
    Event Number
    82178
    Firm
    O-Two Medical Technologies, Inc. 45A Armthorpe Road Brampton Canada Ontario
    FEI Number
    3002807836
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 12, 2019
    Posted
    April 4, 2019
    Terminated
    June 29, 2023

    Description

    e500 Automatic Transport Ventilator, Model Number 01EVE500

    Reason

    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.

    Action

    Urgent Medical Device Correction notification letters dated 2/7/19 were sent to customers. An additional letter was sent to customers on 3/4/19.

    Distribution

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

    Quantity

    136