BEUDAMED
    FDA Recall Terminated

    PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.

    Recall: Z-1774-2013 · Initiated March 27, 2012

    Recall

    Recall Number
    Z-1774-2013
    Event Number
    65688
    Firm
    Topcon Medical Laser Systems, Inc
    FEI Number
    2939653
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 27, 2012
    Posted
    July 19, 2013
    Terminated
    July 19, 2013
    Address
    3130 Coronado Dr, Santa Clara, CA, 95054-3205

    Description

    PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.

    Reason

    When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.

    Action

    Initial notification was sent on March 27, 2012 to all TMLS Distribution Partners and Sales Representative. This was followed by a follow up notification on June 4, 2012. A final notice was sent on February 11, 2013 to all those who had not sent documentation that the field action had been implemented.

    Distribution

    Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.

    Quantity

    7 US, 33 foreign