CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
FDA Recall Z-0727-2020 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeDSI
Date Initiated2019-11-12
Date Terminated2026-03-02
Product Quantity10661 units
Reason for Recall
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.
Firm 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 protects against these potential concerns and mitigates the risk.
Root Cause
Software in the Use Environment
Distribution Pattern
Worldwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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