BEUDAMED
    FDA Enforcement Class I Terminated

    Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

    Recall: Z-2076-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2076-2012
    Event ID
    62007
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    May 25, 2012
    Classification Date
    July 26, 2012
    Termination Date
    May 13, 2014
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

    Reason

    The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.

    Code Info

    not available

    Distribution

    US Nationwide Distribution

    Quantity

    112,912 units total (106,888 units in US)