Patient Telemetry Server Potential Loss of ECG and SpO2 Monitoring Function
GE HealthCare CARESCAPE Telemetry Server (ARK-2250L) may lose ECG and SpO2 monitoring capability during network communication failures. Approximately 1,249 units have been recalled worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential to interrupt critical patient monitoring (ECG, SpO2) due to network communication failure. No injuries reported. Meets rubric criterion for high-severity 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L is a patient monitoring device used in hospital settings to continuously track patients' heart rhythms (ECG) and oxygen saturation (SpO2). The recall affects approximately 1,249 units that were distributed worldwide.
The device may experience potential loss of ECG and SpO2 monitoring capability when a persistent "no communication" or "off network" condition occurs at the CARESCAPE Central Station or CIC Pro Clinical Information Center. GE HealthCare characterizes this situation as unlikely but recognizes it as a potential risk to monitoring continuity.
Healthcare facilities using these devices should monitor their system connectivity and network status to ensure continuous patient monitoring capability. Affected devices can be identified by the listed serial numbers beginning with KSA. Facilities should contact GE HealthCare with any questions about their specific devices or systems.
The recalled product
- 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)
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Hazard
- monitoring-loss
- network-communication-failure
- ecg-loss
- spo2-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- no UDI
- Serial Number or Sales Order Number: KSA7013962
- KSA5646256
- KSA5646267
- KSA5646268
- KSA5646321
- KSA5646328
- KSA5646242
- KSA5646251
- KSA5646257
- KSA5646284
- KSA5646289
- KSA5646295
- KSA5646297
- KSA5646306
- KSA5646314
- KSA6689326
- KSA6689333
- KSA6689378
- KSA7162600
Distribution
Distribution scope not specified by the agency.
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