BEUDAMED
    FDA Enforcement Class II Terminated

    MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.

    Recall: Z-2316-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2316-2018
    Event ID
    80392
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wescam Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    May 8, 2018
    Classification Date
    July 15, 2018
    Termination Date
    August 24, 2021
    Address
    649 North Service Rd, Burlington, Ontario, N/A, Canada

    Description

    MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.

    Reason

    Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure limit.

    Code Info

    L3 Wescam MX-10, part numbers 44620-203, 44620-211, 44620-213, 44620-215, 44620-221,4620-258, 44620-263, 44620-277, 45840-13, 45840-20, and 45840-23

    Distribution

    US Nationwide Distribution

    Quantity

    29