BEUDAMED
    FDA Enforcement Class II Ongoing

    Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.

    Recall: Z-0379-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0379-2018
    Event ID
    78885
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carl Zeiss Metrology Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    November 14, 2017
    Classification Date
    January 26, 2018
    Address
    6250 Sycamore Ln N, Maple Grove, MN, 55369-6310, United States

    Description

    Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.

    Reason

    Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.

    Code Info

    Serial Numbers: 152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342

    Distribution

    Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.

    Quantity

    13 US