The Recall Desk
HighFDA (Devices)·Z-0726-2020·Announced 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.

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 medical device with cybersecurity vulnerabilities that could compromise patient data or device integrity. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 41,848 units of the CIC Pro Clinical Information Center Central Station. These devices are intended to provide clinicians with adult, pediatric, and neonatal patient data in a centralized location within a hospital or clinical environment.

The recall is due to cybersecurity vulnerabilities identified in certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1, and Central Information Center (CIC) systems when connected to Mission Critical (MC) and/or Information Exchange (IX) networks. The source text does not specify reported injuries, illnesses, or specific attack incidents.

The affected units were distributed worldwide. Healthcare facilities should check their device serial numbers against the list provided in the official recall notice and contact GE Healthcare for remediation instructions.

The recalled product

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
Manufacturer
GE Healthcare, LLC
Affected units
41,848

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 →