BEUDAMED
    FDA Enforcement Class II Terminated

    sterEOS workstation

    Recall: Z-3188-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3188-2018
    Event ID
    80938
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EOS Imaging
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    August 1, 2018
    Classification Date
    September 18, 2018
    Termination Date
    August 15, 2022
    Address
    4 Ieme Etage, 10 Rue Mercoeur, Paris, N/A, N/A, France

    Description

    sterEOS workstation

    Reason

    3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.

    Code Info

    All software versions are impacted

    Distribution

    US nationwide

    Quantity

    17 units