GE Healthcare, LLC recalls CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal…

Recall date

November 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0727-2020

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.