GE HealthCare CARESCAPE Telemetry Server v5 recalled for potential loss of ECG and SpO2 monitoring
What this means
GE HealthCare identified a rare condition in CARESCAPE Telemetry Server v5.0 and v6.0 where a persistent network communication failure at the central monitoring station can result in loss of ECG and SpO2 (heart rhythm and blood oxygen) monitoring. The problem occurs only when the system is in a "NO COMM" or "OFF NETWORK" state at the central station.
- Check your facility's CARESCAPE Telemetry Server serial number against the list of affected units provided by GE HealthCare.
- Contact GE HealthCare immediately if your system is affected.
- Ensure backup cardiac monitoring procedures are in place for patients until the issue is resolved.
- Do not ignore network communication alerts on the central monitoring station.
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-2242-2026More 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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