Ge Medical Systems Information Technologies Inc: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Recall Summary GE HealthCare is recalling the CARESCAPE TELEMETRY SERVER V5 ATO MODEL and related ApexPro CARESCAPE Telemetry Server systems used to monitor patients' heart rhythms and oxygen levels in hospitals. Under certain network conditions, these systems may stop transmitting patient ECG and oxygen monitoring data to the central monitoring station. This is a Class II recall affecting devices distributed worldwide.
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Product
- GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1158993d-0011-4ca7-9c30-59d7b36dccaa