The Recall Desk

FDA (Devices) recall action 84372

GE Healthcare, LLC recalled 3 products on 2020-01-01

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-01-01
Critical
0
Units
63,856

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2020-01-01

    GE Healthcare ApexPro Telemetry System Recalled for Cybersecurity Vulnerabilities

    GE Healthcare is recalling 11,347 ApexPro Telemetry Systems worldwide due to cybersecurity vulnerabilities in specific server versions connected to hospital networks.

    Product
    ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-01-01

    GE Healthcare Recalls CIC Pro Central Stations Due to Cybersecurity Vulnerabilities

    GE Healthcare is recalling 41,848 CIC Pro Clinical Information Center Central Stations worldwide due to cybersecurity vulnerabilities in connected telemetry systems.

    Product
    CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-01-01

    GE Healthcare CARESCAPE Central Station Recalled for Cybersecurity Vulnerabilities

    GE Healthcare is recalling CARESCAPE Central Station units due to cybersecurity vulnerabilities in specific network-connected versions.

    Product
    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.…
    Category
    Distribution
    0 states