The Recall Desk
HighFDA (Devices)·Z-0725-2020·Announced 2020-01-01

GE Healthcare ApexPro Telemetry System Recalled for Cybersecurity Vulnerabilities

GE Healthcare is recalling 11,347 ApexPro Telemetry Systems worldwide due to cybersecurity vulnerabilities in specific server versions connected to hospital networks.

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) with a cybersecurity vulnerability where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 11,347 ApexPro Telemetry Systems that were distributed worldwide. 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.

The vulnerability exists when these systems are connected to Mission Critical (MC) and/or Information Exchange (IX) networks, making them susceptible to cyber-attacks. The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire and monitor physiological data for ambulating patients within a defined coverage area.

The source text does not specify reported injuries, illnesses, or deaths associated with this recall. Healthcare facilities should verify if their systems are affected by checking the serial numbers listed in the official recall notice and contact GE Healthcare for remediation instructions.

The recalled product

Product
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.
Manufacturer
GE Healthcare, LLC
Affected units
11,347

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 →