BEUDAMED
    FDA Enforcement Class II Terminated

    v|tome|x L Series non-destructive testing cabinet x-ray systems

    Recall: Z-0442-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0442-2021
    Event ID
    86620
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ge Inspection Technologies Llc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    November 25, 2020
    Initiation Date
    September 29, 2020
    Classification Date
    November 13, 2020
    Termination Date
    May 2, 2023
    Address
    721 Visions Dr, N/A, Skaneateles Falls, NY, 13153-5314, United States

    Description

    v|tome|x L Series non-destructive testing cabinet x-ray systems

    Reason

    It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide "Audible and visible warning signals within the cabinet" if the "warm up" mode was not completed after initializing the system when first turned on.

    Code Info

    v/tome/x L Series (L240, L300 or L450)

    Distribution

    USA Canada

    Quantity

    N/A