BEUDAMED
    FDA Recall Terminated

    Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine

    Recall: Z-0350-2007 · Initiated November 10, 2006

    Recall

    Recall Number
    Z-0350-2007
    Event Number
    37023
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2006
    Posted
    January 25, 2007
    Terminated
    February 5, 2007
    Address
    1140 US Highway 22, Bridgewater, NJ, 08807-2958

    Description

    Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine

    Reason

    The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.

    Action

    Letters were mailed to customers on 11/10/2006 by Federal Express.

    Distribution

    Hospitals in CA, NC, FL, WY, NY and WV.S

    Quantity

    13 units