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