BEUDAMED
    FDA Enforcement Class I Terminated

    Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.

    Recall: Z-1298-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1298-2014
    Event ID
    67502
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    February 7, 2014
    Classification Date
    March 28, 2014
    Termination Date
    August 17, 2015
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.

    Reason

    The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

    Code Info

    all lots

    Distribution

    Nationwide Distribution

    Quantity

    1544