BEUDAMED
    FDA Enforcement Class II Ongoing

    True 3D Viewer, Model: EP-00003

    Recall: Z-1785-2025 · Reported May 28, 2025

    Enforcement

    Recall Number
    Z-1785-2025
    Event ID
    96674
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Echopixel, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2025
    Initiation Date
    February 21, 2018
    Classification Date
    May 16, 2025
    Address
    780 Montague Expy Ste 305, N/A, San Jose, CA, 95131-1317, United States

    Description

    True 3D Viewer, Model: EP-00003

    Reason

    With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.

    Code Info

    UDI-DI: 00851325007003. Full release software versions: 1.6.1.3080.428, released 13-Apr-2017 1.6.2.3670.435, released 07-Dec-2017 Develop Versions, for research use: 0.00.2695.422, released 15-Feb-2017 0.00.2927.423, released 15-Feb-2017 0.00.2964.423, released 24-Feb-2017 0.00.3102.428, released 04-Apr-2017 0.00.3245.428, released 05-May-2017 0.00.3302.431, released 02-Jun-2017 0.00.3344.432, released 18-Jul-2017 0.00.3412.433, released 14-Aug-2017 0.00.3656.442, released 09-Nov-2017 0.00.3669.442, released 05-Dec-2017 0.00.3683.445, released 02-Jan-2018 0.00.3702.447, released 11-Jan-2018 0.00.3730.447, released 08-Feb-2018

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA.

    Quantity

    18