GE (NYSE:GE) issued an urgent field safety notice in the United Kingdom for an issue with the server of its ApexPro telemetry system.
The issue with the telemetry system is that the central monitoring station or bedside monitor may not provide visual or audible alarms for electrocardiogram arrhythmias, lead failures or SpO2 monitoring when affected. The ApexPro is designed to provide vital patient information in healthcare settings.
GE informed users that it is safe to continue using affected devices until the corrective action is completed, but offered instructions in the notice for how to mitigate the risk during use. The company instructed users to begin taking action by Jan. 3, 2020, and to complete the action by Jan. 17, 2020.
Affected ApexPro telemetry server hardware platforms include:
- Nightshade
- Omnitech
- BCM
- ATS and
- CTS/MP100
Software versions 3.9, 4.0, 4.1, 4.2 and 4.3 are affected.
Last month, the company issued a similar field safety notice in the U.S. to warn of six potential safety issues with its ApexPro telemetry system under certain conditions.
When the ApexPro telemetry transmitter is out of wireless range, its battery has been depleted or a communication failure between the server and transmitter has taken place, a “no telem” condition occurs. This condition, along with “ECG leads fail,” system time changes and system restarts, is related to the potential safety issues.
However, none of the affected server hardware versions above were mentioned among the affected products in GE’s previous field safety notice.
