GE CARESCAPE Telemetry Server monitoring loss during network connectivity failures
GE HealthCare CARESCAPE Telemetry Server may lose ECG and SpO2 monitoring capability during persistent network connectivity failures at the Central Station, potentially delaying detection of patient changes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for patient harm (loss of vital sign monitoring during network connectivity failures) where no injuries have been reported. Qualifies as risk-of-harm product where injury has not yet been reported per the rubric.
Plain-English summary
GE HealthCare has become aware of a potential issue with the CARESCAPE Telemetry Server, a physiological patient monitor used in clinical settings to track ECG rhythm and oxygen saturation (SpO2) with arrhythmia detection and alerting capability. When a persistent network communication loss or offline network condition occurs at the CARESCAPE Central Station or Clinical Information Center, the monitoring system may lose its ability to transmit ECG and SpO2 data from the patient monitor to the central station.
During such a network connectivity failure, vital sign monitoring data may not reach nursing staff, potentially delaying detection of patient deterioration or dangerous arrhythmias. Although the source describes this scenario as unlikely, loss of telemetry monitoring in a hospital environment represents a risk to patient safety. Approximately 2,366 units have been distributed worldwide.
Healthcare facilities should ensure robust network connectivity between patient monitors and central monitoring stations, implement redundant communication pathways where possible, and confirm that staff are trained on manual patient monitoring procedures to use during any communication loss. Facilities should contact GE Medical Systems Information Technologies Inc for technical guidance, available patches, or other mitigation measures.
The recalled product
- 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)
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Hazard
- monitoring-loss
- network-connectivity-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- No UDI
- Serial Number or Sales Order Number: KSA7536146
- KSA7536158
- KSA7536159
- KSA7550156
- KSA7550158
- KSA7550159
- KSA7667317
- KSA7754389
- KSA7769597
- KSA7769610
- KSA7769612
- KSA7773420
- KSA7773431
- KSA7773440
- KSA7120704
- KSA7120767
- KSA6964886
- KSA6808842
- KSA6808852
Distribution
Distribution scope not specified by the agency.
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