BEUDAMED
    FDA Enforcement Class II Terminated

    YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

    Recall: Z-2106-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2106-2019
    Event ID
    83295
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Comet Technologies Usa Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    October 1, 2018
    Classification Date
    August 7, 2019
    Termination Date
    June 13, 2024
    Address
    100 Trap Falls Rd, N/A, Shelton, CT, 06484-4604, United States

    Description

    YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

    Reason

    Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only the movement of the door.

    Code Info

    X-Ray Systems

    Distribution

    US Nationwide Distribution

    Quantity

    93