BEUDAMED
    FDA Enforcement Class II Terminated

    Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.

    Recall: Z-0952-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0952-2021
    Event ID
    87086
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Topcon Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 10, 2021
    Initiation Date
    December 18, 2020
    Classification Date
    February 4, 2021
    Termination Date
    October 19, 2022
    Address
    111 Bauer Dr, Oakland, NJ, 07436-3123, United States

    Description

    Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.

    Reason

    Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record

    Code Info

    Software Version 3.1

    Distribution

    AZ, MO, NC, NY, PA, TX

    Quantity

    13 units