PlainRecalls
FDA Devices Moderate Class II Completed

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.

Reported: January 1, 2020 Initiated: November 12, 2019 #Z-0727-2020

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
10661 units
Distribution
Worldwide distribution.
Location
Waukesha, WI

Frequently Asked Questions

What product 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.. Recalled by GE Healthcare, LLC. Units affected: 10661 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2020. Severity: Moderate. Recall number: Z-0727-2020.

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