Ge Medical Systems Information Technologies Inc: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Recall Summary GE HealthCare is recalling the CARESCAPE Telemetry Server (versions 5.0 and 6.0) used to monitor patients' heart rhythms and oxygen levels because it may stop transmitting ECG and SpO2 data to the central monitoring station under certain network conditions. This Class II recall affects the ARK-2250L telemetry server and related equipment distributed worldwide in healthcare facilities. The loss of monitoring data could prevent clinicians from detecting dangerous heart rhythm changes in patients.
- Recalling firm
- GE Medical Systems Information Technologies Inc
- 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)
- 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).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-24
- Status
- Open, Classified
- Distribution
- Worldwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f39e729f-fa22-4d83-a8b6-d4d35a1abc9a