BEUDAMED
    FDA Recall Terminated

    HealthPax Cranial Electrotherapy Stimulator

    Recall: Z-1242-2007 · Initiated July 19, 2007

    Recall

    Recall Number
    Z-1242-2007
    Event Number
    38459
    Firm
    Health Directions, Inc
    FEI Number
    2529026
    Product Code
    JXK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 19, 2007
    Posted
    September 26, 2007
    Terminated
    June 3, 2008
    Address
    1609 Woodbourne Rd, Ste 203b, Levittown, PA, 19057-1538

    Description

    HealthPax Cranial Electrotherapy Stimulator

    Reason

    Peak voltage test result not in acceptable limits.

    Action

    The recalling firm sent a recall letter 07/30/2007 to all their customers. The letter indicated that it is necessary to return the product for testing and the device will either be returned or if necessary replaced. Each unit will be tested with an oscilloscope device to determine whether it meets or fails design specifications. The recalling firm will reimburse shipping costs.

    Distribution

    Worldwide, including USA, Canada, Ireland, and India.

    Quantity

    212 units