BEUDAMED
    FDA Recall Terminated

    Dispersive Electrodes packaged in an 8x10 plastic container.

    Recall: Z-1076-04 · Initiated June 16, 2004

    Recall

    Recall Number
    Z-1076-04
    Event Number
    29383
    Firm
    Rita Medical Systems
    FEI Number
    1000523114
    Product Code
    JOS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 16, 2004
    Posted
    July 20, 2004
    Terminated
    October 25, 2004
    Address
    967 N Shoreline Blvd, Mountain View, CA, 94043-1932

    Description

    Dispersive Electrodes packaged in an 8x10 plastic container.

    Reason

    Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.

    Action

    Each hospital that has been shipped the devices will receive a recall letter during the week of june 21, 2004 with materials for return shipping. Field representatives will receive notice of the recall, and will return any unused devices and document consumed devices.

    Distribution

    Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers

    Quantity

    468 sets (each set consists of two pads)