GE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
GE HealthCare is recalling CARESCAPE Telemetry Server v5 (476 units) because network failures can cause loss of ECG and SpO2 monitoring at the central station. Affected systems are used in healthcare facilities 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 with potential for patient harm (loss of critical cardiac and oxygen monitoring) but no reported illnesses or injuries described in the source. Per the rubric, risk-of-harm products where injury has not been reported receive a High (3) score.
Plain-English summary
GE HealthCare has issued a recall for CARESCAPE TELEMETRY SERVER V5 ATO MODEL devices (476 units distributed worldwide). These devices are used to monitor patients' electrocardiogram (ECG) and blood oxygen saturation (SpO2) levels in healthcare settings.
A potential issue has been identified where ECG and SpO2 monitoring can be lost when the CARESCAPE Central Station or CIC Pro Clinical Information Center experiences a persistent network communication failure or goes offline.
The recalled devices are identified by reference number 2063702-101 and product code SS9. Specific serial numbers for affected units are listed in the FDA recall notice. The system operates in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) software versions v5.0 and v6.0.
The recalled product
- 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)
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Hazard
- patient-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 (20)
- UDI (01)00840682144773(10)v5.0.2R1C1
- Serial Number or Sales Order Number: SS924160026SA
- SS921080002SA
- SS923080001SA
- SS923080006SA
- SS922460008SA
- SS921320004SA
- SS921320010SA
- SS921320012SA
- SS922120001SA
- SS921210005SA
- SS921060024SA
- SS921060026SA
- SS924290077SA
- SS923290011SA
- SS923290012SA
- SS923290013SA
- SS923290014SA
- SS921520004SA
- SS922080001SA
Distribution
Distribution scope not specified by the agency.
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