Spacelabs Healthcare, Inc. is recalling 2,265 Xhibit Telemetry Receivers (Model 96280) because a software issue can cause the systems to shut down and restart unexpectedly. During this restart, which lasts about 1 to 1.5 minutes, the screen will display an "Offline" message and the system will stop monitoring patient data. If a critical medical event occurs while the system is restarting, hospital staff may not be alerted, which could delay necessary medical care. No injuries have been reported to date.
A Windows proxy issue causes the telemetry receiver to reboot, creating a temporary gap in patient monitoring. During this period, medical staff cannot see patient data, which may lead to undetected clinical events and delayed medical intervention.
Relates to Service Manuals P/N 070-2409-07 and Prior.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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