GE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
GE Medical Systems is recalling APEXPRO v5.0 and v6.0 telemetry monitoring systems due to potential loss of ECG and SpO2 monitoring during network connectivity issues. The recall affects 14 units distributed 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 loss of critical patient monitoring capability (ECG and SpO2). No illnesses or injuries have been reported, but the loss of these vital monitoring functions during network connectivity issues represents a high-risk patient safety condition that meets the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
GE Medical Systems is recalling APEXPRO versions v5.0 and v6.0 patient monitoring systems, including the Software Disaster Recovery USB Kit (REF #2108523-01) and the ApexPro CARESCAPE Telemetry Server (CTS). These systems can experience a loss of ECG and SpO2 monitoring when a persistent network connectivity issue (NO COMM or OFF NETWORK condition) occurs at the CARESCAPE Central Station or CIC Pro Clinical Information Center.
The loss of ECG and SpO2 signals removes critical information for observing patient cardiac and respiratory status. This condition can occur unexpectedly during network outages and affects the system's ability to transmit or display vital monitoring data.
The recall affects 14 units distributed worldwide. Affected units bear the following serial numbers: SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, and SS921120010SA. Healthcare facilities using these systems should verify serial numbers and contact GE Medical Systems for information about remediation or replacement.
The recalled product
- Product
- GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Hazard
- 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 (15)
- UDI none
- Serial number or Sales Order number SS921120014SA
- SS921120017SA
- SS921120021SA
- SS921120018SA
- SS921120020SA
- SS920390001SA
- SS921120007SA
- SS921120008SA
- SS921120012SA
- SS921120016SA
- SS920500001SA
- SS920500002SA
- SS921120009SA
- SS921120010SA.
Distribution
Distribution scope not specified by the agency.
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