GE Medical Systems Information Technologies Inc — Class II: GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-
GE HealthCare initiated a Class II recall for the CARESCAPE Telemetry Server (CTS) due to potential loss of ECG and SpO2 monitoring resulting from persistent 'NO COMM' or 'OFF NETWORK' conditions at central stations. The issue affects ApexPro CTS versions 5.0 and 6.0 when used with specific infrastructure like the CIC Pro Clinical Information Center.
GE Medical Systems Information Technologies Inc, clinical engineering departments, and healthcare facilities utilizing ApexPro CARESCAPE Telemetry Servers (CTS) v5.0 and v6.0 for patient monitoring.
The loss of physiological monitoring (ECG and SpO2) represents a significant clinical risk, as it could delay response to life-threatening events. From a regulatory perspective, this suggests a potential vulnerability in the network communication or software stability of the telemetry server environment. This recall emphasizes the importance of robust interface monitoring between central clinical stations and remote telemetry servers.
QA and clinical engineering teams should identify affected CTS v5.0 and v6.0 units and evaluate monitoring workflows for 'NO COMM' or 'OFF NETWORK' alerts. Regulatory teams should ensure that all field safety notices or mitigation instructions provided by the manufacturer are documented within the firm's post-market surveillance and CAPA systems.
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 TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; 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