BEUDAMED
    FDA Enforcement Class I Terminated

    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    Recall: Z-2343-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2343-2015
    Event ID
    71702
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    July 13, 2015
    Classification Date
    August 14, 2015
    Termination Date
    March 1, 2017
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    Reason

    The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

    Code Info

    Catalog Number(s): 8416400, 8417400

    Distribution

    Nationwide Distribution.

    Quantity

    2081