BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOSMOS

    MDR report key: 22118943 · Received May 30, 2025

    Report

    Report Number
    3013757696-2025-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 8, 2024
    Manufacturer
    ECHONOUS, INC.
    Product Code
    IYN
    UDI-DI
    09353278000717
    PMA / PMN Number
    K212100
    Removal / Correction Number
    RES 94709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ECHONOUS NOTIFIED FDA OF A VOLUNTARY RECALL ON (B)(6) 2024, WITHIN 10 WORKING DAYS FROM AWARENESS. FDA INITIATED RECALL RES 94709 ON (B)(6), 2024. TO DATE, ECHONOUS HAS RECEIVED NO COMPLAINTS RELATED TO THIS ISSUE. GIVEN THERE WAS POTENTIAL FOR SERIOUS INJURY, THIS MDR IS BEING SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, ECHONOUS DETECTED A SOFTWARE ANOMALY IN THE MODULE RESPONSIBLE FOR CREATING DICOM FILES FOR EXPORT OR ARCHIVE. ALTHOUGH THE IMAGES AND CLIPS ARE BEING STORED CORRECTLY IN THE DICOM FILES CREATED BY OUR IOS SOFTWARE, THE PIXEL INCREMENT VALUES PUT IN THE METADATA ARE INCORRECT. AS A RESULT, THE MEASUREMENTS PERFORMED ON ARCHIVED OR EXPORTED DICOM IMAGES/CLIPS WILL BE INCORRECT (10% TO 15% WITH B-MODE, ~ 2% IN M-MODE DISTANCE, CW/PW >10X). THE DEFECT IS ONLY PRESENT WHEN PERFORMING MEASUREMENTS ON EXPORTED/ARCHIVED FILES USING THIRD-PARTY DICOM SOFTWARE. MEASUREMENTS PERFORMED WITHIN THE KOSMOS APP ARE UNAFFECTED BY THIS DEFECT. ADDITIONALLY, THIS SOFTWARE BUG IS ONLY PRESENT IN THE IOS VERSION OF THE KOSMOS APP. KOSMOS AND THE KOSMOS ANDROID APP REMAIN UNAFFECTED BY THIS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10048 KOSMOS KOSMOS IYN ECHONOUS, INC. P007639, P0079444 V 1.0, V2.1, V2.2 09353278000717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other