BEUDAMED
    FDA Enforcement Class III 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 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2530-2018
    Event ID
    80296
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Human Design Medical Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 1, 2018
    Initiation Date
    May 8, 2018
    Classification Date
    July 23, 2018
    Termination Date
    May 4, 2020
    Address
    119 Braintree St Ste 703, N/A, Boston, MA, 02134-1642, United States

    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.

    Code Info

    Pending

    Distribution

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

    Quantity

    45