BEUDAMED
    FDA Recall Terminated

    HealthPax (HP-1). Cranial Electrotherapy Stimulator

    Recall: Z-0019-05 · Initiated April 8, 2004

    Recall

    Recall Number
    Z-0019-05
    Event Number
    28852
    Firm
    Health Directions, Inc
    FEI Number
    2529026
    Product Code
    JXK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 8, 2004
    Posted
    October 14, 2004
    Terminated
    October 14, 2004
    Address
    81 Big Oak Rd, Morrisville, PA, 19067-7801

    Description

    HealthPax (HP-1). Cranial Electrotherapy Stimulator

    Reason

    Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device

    Action

    The recalling firm issued a letter to their customers dated 4/8/04 informing them of the problem. The letter explained that the manual was changed due to unacceptable text. The consignees were instructed to change the user manuals prior to shipping.

    Distribution

    The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA.

    Quantity

    3475 units