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. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
Recall
- Recall Number
- Z-0725-2020
- Event Number
- 84372
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- DSI
- Status
- Terminated
- Root Cause
- Software in the Use Environment
- Initiated
- November 12, 2019
- Terminated
- March 2, 2026
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
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. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
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.
The firm disseminated the notices by mail on 11/12/2019. The letter identified the security vulnerability of certain GE Central Stations and ApexPro Telemetry servers and provided additional best practices, ensuring the following: 1. MC and IX Networks are isolated; 2. MC and IX Router/Firewalls block incoming traffic, as applicable; 3. Restricted physical access to Central Stations, Telemetry Servers, MC network and IX network; 4. Default passwords are changed as applicable; and 5. Password management best practices are adhered to Ensuring the networks are properly configured and isolated protects against these potential concerns and mitigates the risk.
Worldwide distribution.
11347 devices