Health product recall

Xhibit Telemetry Receiver (Xtr)

Last updated

Summary

Product
Xhibit Telemetry Receiver (Xtr)
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Xhibit Telemetry Receiver (Xtr) More than 10 numbers, contact manufacturer. 96280

Issue

Xtr systems may experience a windows proxy issue causing the system to shut down and restart.
While the Xtr system is running and telemetry devices are being monitored from Xhibit, the system may shut down, which will cause a temporary loss of monitoring. During this time, telemetry zones on the Xhibit will state "offline" and monitoring will be lost until the system has restarted and comes back online.
The system reset takes approximately 1 to 1.5 minutes and the telemetry reading is expected to be down for the duration of the reset.
There are no associated alarms triggered upon the system resetting. During the reset, tuned channels will show "offline" in the respective central station patient zone.
Once the system has reset and parameters are back online, parameter settings will come back online in the same state as defined prior to the reset.
In the case of an unplanned shutdown due to this error, the clinical user does not need to take any action during the reset process and should not try to retune the transmitters; the system will reboot and come back online on its own.

Recall start date: December 24, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Spacelabs Healthcare Inc.
35301 Se Center Street, Snoqualmie, Washington, United States, 98065
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76831

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