This is part of a larger recall. The most authoritative record is FDA-Device / Z-2243-2026.
GE HealthCare CARESCAPE Telemetry Server recalled for potential loss of heart and oxygen monitoring
What this means
GE HealthCare has identified a software issue in certain CARESCAPE Telemetry Server systems (versions 5.0 and 6.0) that can cause loss of ECG (heart rhythm) and SpO2 (oxygen level) monitoring when the central station loses network connection. This can occur with specific hardware models and serial numbers distributed in North America.
- If your facility uses a CARESCAPE Telemetry Server ARK-2250L (product code KSA), check the serial number against the affected list provided by GE HealthCare.
- Contact GE HealthCare support immediately if your serial number is on the recall list.
- Do not rely solely on the affected telemetry system until you receive instructions or a corrective update from GE HealthCare.
- Ensure alternative monitoring is in place for affected patient care areas.
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-2246-2026Want us to check the next one for you?
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