BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1774-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1774-2013
    Event ID
    65688
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Topcon Medical Laser Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    March 27, 2012
    Classification Date
    July 19, 2013
    Termination Date
    July 19, 2013
    Address
    3130 Coronado Dr, N/A, Santa Clara, CA, 95054-3205, United States

    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.

    Code Info

    PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211

    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