BEUDAMED
    FDA Enforcement Class III Terminated

    ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.

    Recall: Z-1050-2013 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1050-2013
    Event ID
    64386
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    February 15, 2013
    Classification Date
    April 3, 2013
    Termination Date
    August 11, 2014
    Address
    34 Bunsen, N/A, Irvine, CA, 92618-4210, United States

    Description

    ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.

    Reason

    Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.

    Code Info

    All serial numbers

    Distribution

    Nationwide Distribution

    Quantity

    180 units