BEUDAMED
    FDA Enforcement Class I Terminated

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

    Recall: Z-1098-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1098-2013
    Event ID
    64728
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 6, 2013
    Classification Date
    April 15, 2013
    Termination Date
    September 2, 2014
    Address
    3750 Torrey View Ct, N/A, San Diego, CA, 92130-2622, United States

    Description

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

    Reason

    The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.

    Code Info

    unit model 8015 with software version 9.12

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia and China.

    Quantity

    9,241 units