BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0379-2018 · Initiated November 14, 2017

    Recall

    Recall Number
    Z-0379-2018
    Event Number
    78885
    Firm
    Carl Zeiss Metrology Inc
    FEI Number
    3003902825
    Product Code
    RCE
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    November 14, 2017
    Address
    6250 Sycamore Ln N, Maple Grove, MN, 55369-6310

    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.

    Action

    Zeiss sent an Safety Notice Letter dated September 28, 2017, to the customers advising them of the recall. The affected device was identified as well as the issue involved. Customers are to complete and return the confirmation- waiver form. During the next scheduled service event, a ZEISS field service technician will update the Metrotom operating system. The corrections are to be made free of charge, and will be completed by March 2018. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (763) 203-4267.

    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