GE Medical Systems Information Technologies Inc — Class II: GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in con
GE Medical Systems Information Technologies Inc initiated a Class II recall for ApexPro v6.0 eDelivery Software due to a risk of losing ECG and SpO2 monitoring during persistent 'NO COMM' or 'OFF NETWORK' conditions at the central monitoring stations.
Clinical facilities using ApexPro CARESCAPE Telemetry Servers (v5.0 and v6.0) in conjunction with CARESCAPE Central Stations or CIC Pro Clinical Information Centers for patient arrhythmia detection and physiological monitoring.
The loss of real-time monitoring for critical parameters like ECG and SpO2 represents a significant clinical risk, particularly for patients requiring arrhythmia detection. From a regulatory perspective, this highlights vulnerabilities in software-dependent telemetry networks where communication failures can lead to a cessation of monitoring rather than a fail-safe state. Maintenance of continuous connectivity and alarm integrity is a high priority for post-market surveillance of monitoring systems.
Biomedical and QA teams should identify installed units running ApexPro v5.0 or v6.0 and verify connectivity stability. Ensure clinical staff are aware of the risk of 'NO COMM' or 'OFF NETWORK' status and have manual monitoring protocols in place if telemetry disruptions occur. Maintain documentation of all software remediation steps in the device history file.
Class II. Reason: GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).. Product: GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms). Firm: GE Medical Systems Information Technologies Inc (Waukesha WI United States). Status: Ongoing.
Open in openFDA / FDA.gov