GE HealthCare CARESCAPE Telemetry Server May Lose Cardiac Monitoring
GE HealthCare CARESCAPE Telemetry Servers (versions 5.0 and 6.0) may lose ECG and SpO2 patient monitoring during network connectivity failures. Seven affected units have been identified 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: This is an FDA Class II medical device recall with a risk-of-harm hazard (loss of critical patient monitoring). No illnesses or injuries are reported in the source, and the condition is described as potential and unlikely. Per the rubric, risk-of-harm products where injury has not been reported score at most 3.
Plain-English summary
GE HealthCare's CARESCAPE Telemetry Server (CTS) versions 5.0 and 6.0 is a physiological patient monitoring device used in healthcare settings to track cardiac rhythm (ECG) and blood oxygen saturation (SpO2) at a central station.
Under certain network conditions, the telemetry server may experience a persistent "NO COMM" (no communication) or "OFF NETWORK" condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center. When this occurs, ECG and SpO2 monitoring data may be lost, potentially preventing clinicians from detecting patient deterioration.
The recall affects seven units identified by specific serial numbers. These units have been distributed worldwide. Healthcare facilities with affected devices should contact GE Medical Systems Information Technologies Inc for guidance on remediation or replacement.
The recalled product
- 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)
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Hazard
- ecg-monitoring-loss
- spo2-monitoring-loss
- network-connectivity-failure
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 (7)
- Serial #/Sales Order #: SS920500004SA
- SS920500005SA
- SS920500003SA
- SS920500006SA
- SS921120011SA
- SS921120019SA
- SS921120015SA.
Distribution
Distribution scope not specified by the agency.
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