BEUDAMED
    FDA Enforcement Class II Ongoing

    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

    Recall: Z-1382-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1382-2022
    Event ID
    90433
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Breas Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 20, 2022
    Initiation Date
    June 2, 2022
    Classification Date
    July 13, 2022
    Address
    16 Esquire Rd, North Billerica, MA, 01862-2527, United States

    Description

    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

    Reason

    A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained

    Code Info

    Unique Device Identifier (UDI): UDI 07321822300004. Serial number ranges in scope are: D******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9.

    Distribution

    Nationwide

    Quantity

    1,113 units