BEUDAMED
    FDA Recall Terminated

    Prism Laser 7642 Laser System

    Recall: Z-2600-2011 · Initiated April 27, 2011

    Recall

    Recall Number
    Z-2600-2011
    Event Number
    58804
    Firm
    American Stress Technologies, Inc.
    FEI Number
    3008905686
    Product Code
    REO
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    April 27, 2011
    Posted
    August 29, 2011
    Terminated
    October 13, 2016
    Address
    840 Watercrest Way, Cheswick, PA, 15024

    Description

    Prism Laser 7642 Laser System

    Reason

    It was discovered The Prism 7642 was not certified at the time of delivery. The product lacks the required labeling and the product was sold and delivered without the submission of the Initial Product Report. The product lacks User In formation

    Action

    American Stress Technologies sent a customer notification letter dated April 1, 2011, informing them of the action they have taken to correct this issue. (1) ASTI conducted laser safety tests and checks on May 3,2011 to verify the Prism was compliant with FDA regulations. This was confirmed in a June 17, 2011, electronic mail message. (2) ASTI placed the required labels described in the initial product report on the Prism on May 3, 2011. (3) ASTI delivered updated user manuals to UNO on May 3, 2011, that describe potential laser hazards and the required labeling in the same way as described in the initial product report. (4) ASTI completed the above corrective actions at no cost to UNO as confirmed in a June 20, 2011, electronic mail message. If you have any further questions please call (724) 410-1030

    Distribution

    Nationwide Distribution

    Quantity

    1