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

Starting date:

February 14, 2015

Posting date:

March 6, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-43819

• 
  Reason
• 
  Affected products

Recalled products

1. Bedside Monitor
2. QUBE Compact Monitor

Reason

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.

Affected products