GE HealthCare ApexPro CARESCAPE Telemetry Server recalled for potential loss of patient ECG and SpO2 monitoring
What this means
GE HealthCare has identified a situation where the ApexPro CARESCAPE Telemetry Server (versions 5.0 and 6.0) can lose ECG and SpO2 monitoring data if the system loses network connection to the central monitoring station. This affects 14 units used in hospitals and clinical settings.
- If you operate this system, contact GE HealthCare Service immediately to discuss the issue and available solutions.
- Ensure backup manual monitoring procedures are in place until your system is reviewed.
- Do not rely solely on this system for patient monitoring until confirmed safe by GE Service.
The agency's original wording
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2243-2026Also reported as
- FDA-Device2026-06-03GE HealthCare CARESCAPE Telemetry Server recalled for potential loss of heart and oxygen monitoring
- FDA-Device2026-06-03GE HealthCare ApexPro CARESCAPE Telemetry Server recalled for potential loss of ECG and SpO2 monitoring
- FDA-Device2026-06-03GE HealthCare CARESCAPE Telemetry Server recalled for potential loss of ECG and SpO2 monitoring
- FDA-Device2026-06-03GE HealthCare ApexPro CARESCAPE Telemetry Server recalled for potential loss of patient monitoring
More GE recalls
- FDA-Device2026-09-23GE Carescape Central Station CSCS V3 recalled for patient monitoring delay after restart
- FDA-Device2026-09-02GE Portrait Core Services Software V1.1 recalled for patient monitoring loss and alarm reset risk
- FDA-Device2026-09-02GE PORTRAIT Core Services software update may disable patient monitoring and reset alarms
- FDA-Device2026-09-02GE Portrait Compute and Core Services V1.2 software recalled for patient monitoring loss risk
- FDA-Device2026-09-02GE Portrait Core Services Software v1.0.5 recalled for patient monitoring loss and alarm reset risk
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