BEUDAMED
    FDA Recall Open, Classified

    AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

    Recall: Z-0068-2026 · Initiated September 5, 2025

    Recall

    Recall Number
    Z-0068-2026
    Event Number
    97657
    Firm
    GE Medical Systems, SCS
    FEI Number
    1000284313
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software in the Use Environment
    Initiated
    September 5, 2025
    Posted
    October 8, 2025
    Address
    283 rue de la Miniere Buc France

    Description

    AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

    Reason

    Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

    Action

    On September 5, 2025, firm began deployment of customer letter. Customers were informed they could continue use of their device by following the instructions provided: 1. Ensure the AW Server is installed on a facility internal network, that is not accessible from any public network. If access to AW Server from outside the facility network is desired, this connectivity must be configured to be usable exclusively through the facility s Virtual Private Network (VPN) or equivalent network security solution as described in your AW Server s Pre-Installation Manual that is available in the Customer documentation portal. NOTE: Access management to the facility s internal network on which the AW Server is installed on, and management of the network security solution is under the strict responsibility of the facility. 2. Ensure strong, secure passwords are configured for the AW Server. 3. GE HealthCare recommends that organizations follow security and cybersecurity best practices, including securing the network where AW Server is connected.

    Distribution

    Domestic US distribution nationwide. International distribution worldwide.

    Quantity

    7,302 (1,381 US; 5,921 OUS)