BEUDAMED
    FDA Recall Terminated

    3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048.

    Recall: Z-1236-04 · Initiated September 1, 2003

    Recall

    Recall Number
    Z-1236-04
    Event Number
    29387
    Firm
    Daavlin Distributing Company
    FEI Number
    1526255
    Product Code
    FTC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2003
    Posted
    July 30, 2004
    Terminated
    July 24, 2007
    Address
    205 West Bement Street PO Box 626, Bryan, OH, 43506-0626

    Description

    3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048.

    Reason

    Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.

    Action

    The firm has software patches to correct the programming problems as they are reported by the users. These patches are being installed either by a service representative for the manufacturer or by the customer

    Distribution

    Nation wide plus Canada, the Philippines, Saudi Arabia, Turkey & Germany

    Quantity

    23 units distributed domestically and 23 units distributed to foreign accounts.