BEUDAMED
    FDA Recall Terminated

    Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

    Recall: Z-2530-2018 · Initiated May 8, 2018

    Recall

    Recall Number
    Z-2530-2018
    Event Number
    80296
    Firm
    Human Design Medical Llc
    FEI Number
    3010817335
    Product Code
    NOU
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 8, 2018
    Terminated
    May 4, 2020
    Address
    119 Braintree St, Ste 703, Boston, MA, 02134-1642

    Description

    Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

    Reason

    Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.

    Action

    On May 8, 2018, the firm notified all affected customers via phone to quarantine all affected devices. On May 18, 2018, formal Field Safety Corrective Action letters were sent to all affected customers via FedEx. Customers were asked to remove affected units from use and return to the firm, and to complete and return the Acknowledgement and Product Replacement forms. Customers were informed that the firm would be shipping replacement devices.

    Distribution

    US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.

    Quantity

    45