Recall Z-0725-2020 ยท DSI Detector And Alarm, Arrhythmia
GE Healthcare, LLC
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
| Date | Nov 12, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software in the Use Environment |
| Action | 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 |
| Quantity | 11347 devices |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000779 | APEXPRO TELEMETRY SYSTEM General Electric Medical Systems Information Techn, May 18, 2000 |
| K021325 | MODIFICATION OF APEXPRO TELEMETRY SYSTEM General Electric Medical Systems Information Techn, May 7, 2002 |
| K032369 | MODIFICATION TO: APEXPRO TELEMETRY SYSTEM Ge Medical Systems Information Technologies, Aug 15, 2003 |
| K033365 | APEXPRO FH TELEMETRY SYSTEM Ge Medical Systems Information Technologies, Nov 6, 2003 |
| K080251 | APEXPRO TELEMETRY SYSTEMS Ge Medical Systems Information Technologies, Jun 20, 2008 |