BEUDAMED
    FDA Enforcement Class II Terminated

    Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

    Recall: Z-0820-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0820-2020
    Event ID
    84615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Koios Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2020
    Initiation Date
    December 31, 2019
    Classification Date
    January 17, 2020
    Termination Date
    May 7, 2020
    Address
    500 7th Ave, 8th Fl, New York, NY, 10018-4502, United States

    Description

    Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

    Reason

    Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.

    Code Info

    Models/Versions: 1.2.df61abccd836; 1.2.576fd5569198; 1.3.51a5fadf18dd; 1.3.1.b5c53f1fc08d; 1.3.1.694531bfb9c7; 1.3.1.aaffb0cc2485; 1.3.2.6a67eb8088ed; 1.4.a7e352273dd6; 1.6.1.1*; 1.6.2.1* *Note: versioning scheme was modified to encompass the Build/Commit Number into a fourth digit with the development of version 1.5 (which was never distributed).

    Distribution

    Distributed to customers in NY, NJ, and MO.

    Quantity

    10