BEUDAMED
    FDA Enforcement Class II Terminated

    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)

    Recall: Z-2111-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2111-2021
    Event ID
    88101
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Caption Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 28, 2021
    Initiation Date
    May 19, 2021
    Classification Date
    July 22, 2021
    Termination Date
    January 31, 2023
    Address
    2000 Sierra Point Pkwy Fl 8, N/A, Brisbane, CA, 94005-1845, United States

    Description

    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)

    Reason

    The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.

    Code Info

    All product containing software version 1.2.0

    Distribution

    US : AZ, DE, NY, IL, CT OUS: None

    Quantity

    15 systems