BEUDAMED
    FDA Recall Terminated

    CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    Recall: Z-0727-2020 · Initiated November 12, 2019

    Recall

    Recall Number
    Z-0727-2020
    Event Number
    84372
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    November 12, 2019
    Terminated
    March 2, 2026
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    Reason

    When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.

    Action

    The firm disseminated the notices by mail on 11/12/2019. The letter identified the security vulnerability of certain GE Central Stations and ApexPro Telemetry servers and provided additional best practices, ensuring the following: 1. MC and IX Networks are isolated; 2. MC and IX Router/Firewalls block incoming traffic, as applicable; 3. Restricted physical access to Central Stations, Telemetry Servers, MC network and IX network; 4. Default passwords are changed as applicable; and 5. Password management best practices are adhered to Ensuring the networks are properly configured and isolated protects against these potential concerns and mitigates the risk.

    Distribution

    Worldwide distribution.

    Quantity

    10661 units