BEUDAMED
    FDA Enforcement Class II Terminated

    Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    Recall: Z-0279-2013 · Reported November 21, 2012

    Enforcement

    Recall Number
    Z-0279-2013
    Event ID
    63344
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2012
    Initiation Date
    October 16, 2012
    Classification Date
    November 13, 2012
    Termination Date
    July 11, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586, United States

    Description

    Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    Reason

    Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up

    Code Info

    Catalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05.

    Distribution

    Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI

    Quantity

    15 units