The Recall Desk
HighFDA (Devices)·Z-0727-2020·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.

Plain-English summary

GE Healthcare, LLC is recalling 10,661 units of the CARESCAPE Central Station (CSCS) version 1. The product is intended to provide clinicians with adult, pediatric, and neonatal patient data within a hospital or clinical environment by collecting and displaying information from a network.

The recall was initiated because certain versions of the CARESCAPE Central Station, when connected to Mission Critical (MC) and/or Information Exchange (IX) networks, were identified to have vulnerabilities to a cyber-attack. The affected units were distributed worldwide.

Healthcare facilities should verify if their devices are affected by checking the serial numbers listed in the official recall notice. No specific instructions for consumer action are provided in the source text beyond the identification of the vulnerability.

The recalled product

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. T
Manufacturer
GE Healthcare, LLC
Affected units
10,661

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →