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Rappel de produits de santé

Xper Flex Cardio Physiomonitoring System-Main Unit

Starting date:: August 21, 2017
Posting date:: September 11, 2017
Type of communication:: Medical Device Recall
Subcategory:: Medical Device
Hazard classification:: Type II
Source of recall:: Health Canada
Issue:: Medical Devices
Audience:: General Public, Hospitals, Healthcare Professionals
Identification number:: RA-64496

Reason
Affected products

Reason

Because of intermittent communication between the host system and the flex cardio, it is possible for any of the following conditions to occur:

boom monitor (display) may not display all active waveform and/or vital sign data.
delayed audible and visual alarms at the flex cardio and boom monitor respectively, due to a mismatch between the alarm limits on the host system and the flex cardio/boom monitor.
after patient admission and case initiation at the host system, the case may not be fully transmitted to the flex cardio. In this case, the boom monitor in the exam/procedure room will display vital sign data, but the flex cardio will not provide audible alarms.
after patient discharge and case termination at the host system, case termination may not be transmitted to the flex cardio. In this case, the boom monitor in the exam/procedure room will continue to display vital sign data, and the flex cardio will continue to provide audible alarms.

Affected products