Ge Medical Systems Information Technologies Inc: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Recall Summary GE HealthCare is recalling ApexPro v6.0 eDelivery Software and related telemetry monitoring systems used to track patient heart rhythms and oxygen levels. Under certain network connection problems at the central monitoring station, the system may lose the ability to display ECG and oxygen saturation data, even though monitoring is still occurring at the bedside. This Class II recall affects the software and monitoring equipment distributed worldwide.
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Product
- GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; 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/d3fa3f0d-fdd5-4ebb-bb6b-b2d00a76793a