BEUDAMED
    FDA Enforcement Class II Terminated

    L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.

    Recall: Z-0270-2018 · Reported January 3, 2018

    Enforcement

    Recall Number
    Z-0270-2018
    Event ID
    78658
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    L3 Security & Detection
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    January 3, 2018
    Initiation Date
    October 27, 2017
    Classification Date
    December 22, 2017
    Termination Date
    February 10, 2020
    Address
    10E Commerce Way, N/A, Woburn, MA, 01801-1044, United States

    Description

    L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.

    Reason

    L3 has determined in airport environments, there have been several cases where a small air gap has developed where the entrance or exit tunnels meet up with the main x-ray scanner tunnel. This a gap in x-ray shielding can result in x-ray emissions that exceed the limit in the federal performance standard for cabinet x-ray systems (see 21 CFR ¿ 1020.40(c)(1)).

    Code Info

    Model Number : Examiner 3DX 6000 cabinet x-ray system

    Distribution

    USA (nationwide) Distribution.  Owned and operated by the U.S. Transportation Security Administration. Location of individual products is law enforcement sensitive. TSA HQ is located in Crystal City, Virginia.

    Quantity

    471