Recall Z-0727-2020— GE Healthcare, LLC

Name: FDA recall Z-0727-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-12

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-11-12, terminated 2026-03-02. It names one FDA 510(k) clearance: K133882. 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. 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-11-12
Terminated: 2026-03-02
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K133882 — CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)Ge Medical Systems Information Technologies, Inc.·cleared 2014-04-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.