BEUDAMED
    FDA Recall 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 · Initiated February 15, 2013

    Recall

    Recall Number
    Z-1050-2013
    Event Number
    64386
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    FEI Number
    3002698356
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 15, 2013
    Posted
    April 3, 2013
    Terminated
    August 11, 2014
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    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.

    Action

    Horiba Medical sent an Urgent Safety Notice dated February 15, 2013, to all affected customers. The letter informed the customers that Horiba Medical is informing all ABX Micros IM2 Data Management System customers of their intention to remove the ABX Micros IM2 product from the market. The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. For questions regarding this recall call 949-453-0500, ext 208.

    Distribution

    Nationwide Distribution

    Quantity

    180 units