BEUDAMED
    FDA Recall Terminated

    VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2761, Chattanooga Group.

    Recall: Z-1638-2008 · Initiated February 28, 2008

    Recall

    Recall Number
    Z-1638-2008
    Event Number
    47428
    Firm
    Chattanooga Corp Inc
    FEI Number
    1000342033
    Product Code
    IMG
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 28, 2008
    Posted
    August 6, 2008
    Terminated
    February 19, 2010
    Address
    4717 Adams Rd, Hixson, TN, 37343

    Description

    VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2761, Chattanooga Group.

    Reason

    Device may fail to administer therapy during use.

    Action

    Chattanooga Group sent an Urgent Medical Device Recall letter dated 02/29/2008 to consignees to advise them of problem and the recall. The first group of letters was sent to the distributors via certified mail. The letter stated that the devices were failing and the recall was to the User level. The firm is recalling the devices for repair and calibration. The firm followed with a user notification, by US Mail not certified beginning on March 11, 2008.

    Distribution

    Nationwide Distribution.

    Quantity

    479 devices