Product Wiki · Recalls · Health Canada — Medical Devices

Spacelabs XPEZZON and qube Bedside Monitors (2015-02-14) — recall 52769

Health Canada — Medical Devices · Canada · 2015-03-06 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
52769
Date of alert
2015-03-06
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Spacelabs has received multiple reports of XPREZZON and qube monitors failing to boot up or returning to factory default configuration settings following power on or reset. Reported issues include: a failure to boot following power on or reset, resulting in a failure in monitor operation. loss of network connectivity, which may result in i) an inability to display alarms and data from the affected monitor on central stations and other bedside monitors, or ii) a failure to transmit parameter and alarms from the affected monitor to system printers and spacelabs' Intesys Clinical Suite retrospective database (including the clinical events interface remote notification feature). display of english language when previously configured for another language (the alarm messages displayed in the parameter waveform zone are not affected, as these are stored on a command module and not on the monitor). touchscreen failure where touching the screen does not produce the expected response. The parameter alarms and information are still present and correct once the monitor has completely started up. No one has been injured as a result of these issues. Spacelabs believes this issue is caused by inadequate electrical contact on one of its printed circuit board assemblies.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/spacelabs-xpezzon-and-qube-bed

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