BEUDAMED
    FDA Enforcement Class II Terminated

    Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS

    Recall: Z-0654-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0654-2013
    Event ID
    64029
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lockheed Martin Gyrocam Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    January 21, 2010
    Classification Date
    February 14, 2013
    Termination Date
    February 24, 2015
    Address
    7345 16th St E Bldg C-101, Manatee County, Sarasota, FL, 34243-6808, United States

    Description

    Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS

    Reason

    These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance. Additionally, the manufacturer did not submit a product report to FDA for the camera system.

    Code Info

    Gyrocam DNV Camera System, Serial Numbers: 137, 138, 141, 142, 143, 144, 145, 148, 150, 151, 152, 158, 159, 160, 164, 165, 170, 172, 173, 174, 175, 177; Gyrocam DS Camera System, Serial Numbers: 134, 140, 147, 153, 169, 181; Gyrocam TS Camera System, Serial Numbers: 132, 146, 149, 171, 502.

    Distribution

    Nationwide Distribution

    Quantity

    33 units