BEUDAMED
    FDA Enforcement Class II Terminated

    LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

    Recall: Z-1866-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1866-2014
    Event ID
    68259
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LAP of America Laser Applications, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 2, 2014
    Initiation Date
    March 21, 2014
    Classification Date
    June 24, 2014
    Termination Date
    September 26, 2016
    Address
    161 Commerce Rd Ste 3, N/A, Boynton Beach, FL, 33426-9385, United States

    Description

    LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

    Reason

    While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections. In this case the difference between the red and green projection was up to 2.5mm.

    Code Info

    Product Code: 0007569-0001

    Distribution

    North Carolina

    Quantity

    1 system