Spacelabs Healthcare Telemetry Receiver

• • Ongoing Z-0809-2025 FDA Class II ·initiated 25 Nov 2024

  Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.

• • Ongoing Z-0810-2025 FDA Class II ·initiated 25 Nov 2024

  Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.

• • Ongoing Z-1513-2022 FDA Class II ·initiated 31 May 2022

  Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.

• • Terminated Z-0532-2018 FDA Class II ·initiated 17 Jan 2018 ·on shared 510(k) K141156

  Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.

• • Terminated Z-2886-2016 FDA Class II ·initiated 25 Aug 2016

  The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.

• • Terminated Z-1502-2016 FDA Class II ·initiated 28 Mar 2016

  Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Offline error message for all patients being monitored.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K141156 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Spacelabs Healthcare Inc. →

• What is the Spacelabs Healthcare Telemetry Receiver used for?

  The Spacelabs Healthcare Telemetry Receiver is designed for cardiovascular monitoring, specifically to capture and display ECG waveforms, heart rate, and signal quality metrics in real time. It is intended for arrhythmia detection and alarm functionality, making it ideal for use in hospitals or cardiac care units where continuous cardiac monitoring is required.

• How is the Spacelabs Healthcare Telemetry Receiver supplied and used?

  This device is supplied as a reusable medical device and operates in conjunction with patient-worn telemetry transmitters. It enables remote monitoring of cardiac activity by receiving and processing physiological data from the transmitters, allowing clinicians to monitor patients’ heart rhythms without constant physical presence.

• Is the Spacelabs Healthcare Telemetry Receiver sterile?

  The device does not require specific sterility as it is not intended for direct patient contact beyond its intended use in monitoring. Standard medical device cleaning and maintenance protocols must be followed to ensure proper hygiene and functionality, particularly since it is reusable.

• Can the Spacelabs Healthcare Telemetry Receiver monitor additional parameters besides ECG?

  Yes, the device supports SpO₂ (oxygen saturation) monitoring alongside its primary ECG functionality. This allows for comprehensive cardiac assessment, including both electrical activity of the heart and oxygen levels in the blood, enhancing patient monitoring capabilities.

• What regulatory pathway does the Spacelabs Healthcare Telemetry Receiver follow?

  The device is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K141156. It is classified as a Class II medical device and adheres to regulatory standards for cardiovascular monitoring equipment, ensuring compliance with safety and performance requirements.