BEUDAMED
    FDA Recall Open, Classified

    MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.

    Recall: Z-1938-2025 · Initiated April 25, 2025

    Recall

    Recall Number
    Z-1938-2025
    Event Number
    96830
    Firm
    GE Medical Systems Information Technologies Inc
    FEI Number
    3012359877
    Product Code
    DSI
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 25, 2025
    Posted
    June 10, 2025
    Address
    9900 W Innovation Dr, Milwaukee, WI, 53226-4856

    Description

    MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.

    Reason

    The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.

    Action

    An URGENT MEDICAL DEVICE CORRECTION notification letter dated 4/25/25 was sent to customers. Actions to be taken by Customer/User: MUSE 5 systems have reached their End of Sales/Service Support as of November 1, 2014. Please see attached for the End of Sales/Service Support letter that was previously distributed. GE HealthCare recommends that customers replace or upgrade these systems. If you wish to continue using your MUSE 5 system, you should ensure your IT Department provides ongoing prevention of unauthorized access to the system such as not using a well-known password. If passwords are well-known, please update the credentials according to your organization's password policies or contact GE HealthCare Service or your local Service Representative if necessary. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached Medical Device Notification Acknowledgement Response Form to [email protected]. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    4,277 systems