Recall Z-0726-2020 ยท DSI Detector And Alarm, Arrhythmia
GE Healthcare, LLC
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 is intended to collect information from a network and display this data. This data includes physiological, patient demog
| 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 | 41848 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032370 | CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION Ge Medical Systems Information Technologies, Aug 13, 2003 |
| K053356 | MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION Ge Medical Systems Information Technologies, Apr 19, 2006 |
| K062976 | MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER Ge Medical Systems Information Technologies, Mar 16, 2007 |