Ge Medical Systems Information Technologies Inc: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Recall Summary GE HealthCare is recalling CARESCAPE TELEMETRY SERVER monitors used in hospitals worldwide because they may lose ECG and oxygen level monitoring data when the central station loses network connection. The devices are used to monitor patients' heart rhythms and oxygen levels in medical settings. This is a Class II recall affecting the ARK-2250L model and related telemetry server software versions 5.0 and 6.0.
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Product
- GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, 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/1a5b1c8c-462f-462e-a1ed-9c6156c667eb