BEUDAMED
    FDA Enforcement Class II Ongoing

    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.

    Recall: Z-2325-2024 · Reported July 17, 2024

    Enforcement

    Recall Number
    Z-2325-2024
    Event ID
    94709
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Echonous Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2024
    Initiation Date
    May 9, 2024
    Classification Date
    July 10, 2024
    Address
    8310 154th Ave Ne Ste 200 Bldg B, N/A, Redmond, WA, 98052-6180, United States

    Description

    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.

    Reason

    Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

    Code Info

    Model/UDI-DI/Software versions: P007639/09353278000717/1.0, P007944/09353278000762/ 2.1, 2.2.

    Distribution

    US: ID, TX, WI, KS, IL, GA, MI, CA, OH, FL, AK, UT, MD, NY, NV, CO, ND, WA, DC, LA, KY, MN, HI, NM, TN, NJ, ID, MI, VT, AZ, MO, AL, MA, NC OUS: Denmark, Switzerland, Austria, Italy, France, United Kingdom, Germany, Spain, Romania, Finland, Romania, Australia, India, Hong Kong, Thailand

    Quantity

    272