Ge Medical Systems Information Technologies Inc: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Recall Summary GE HealthCare is recalling certain CARESCAPE Telemetry Server monitoring systems (versions 5.0 and 6.0) used in hospitals worldwide because they may lose ECG and blood oxygen monitoring data when the system loses network connection to the central monitoring station. This is a Class II recall, meaning there is potential for serious harm but the risk of death is not likely. The affected products include the IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER and ApexPro CARESCAPE Telemetry Server systems.

Recalling firm: GE Medical Systems Information Technologies Inc
Product: GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; 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.

Recall details on Nibble Recalls: https://trynibble.app/recalls/b3f69e4f-fb8c-401a-853b-209ed6d22f5f