BEUDAMED
    FDA Recall Terminated

    Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.

    Recall: Z-0320-2008 · Initiated November 9, 2007

    Recall

    Recall Number
    Z-0320-2008
    Event Number
    45852
    Firm
    Chiu Technical Corp
    FEI Number
    3001278563
    Product Code
    HJM
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 9, 2007
    Posted
    January 9, 2008
    Terminated
    October 17, 2012
    Address
    252 Indian Head Road, Kings Park, NY, 11754-4818

    Description

    Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.

    Reason

    Device was marketed without a 510(k).

    Action

    On 11/09/07, the recalling firm started faxing the Recall Letter and response form to its customers, informing them of the recall of the unapproved device to the user level.

    Distribution

    Worldwide: USA, Canada and India

    Quantity

    Domestic: 170 units, Foreign: 21 units