BEUDAMED
    FDA Enforcement Class II Ongoing

    cone-beam CT system

    Recall: Z-1101-2019 · Reported May 1, 2019

    Enforcement

    Recall Number
    Z-1101-2019
    Event ID
    82045
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    KaVo Dental Technologies LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    May 1, 2019
    Initiation Date
    December 31, 2018
    Classification Date
    April 22, 2019
    Address
    11727 Fruehauf Dr, N/A, Charlotte, NC, 28273-6507, United States

    Description

    cone-beam CT system

    Reason

    ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1

    Code Info

    versions 2.1.0 and 2.1.1

    Distribution

    US distribution in NC

    Quantity

    230