Xper Flex Cardio Physiomonitoring System-Main Unit (2018-03-13)

Starting date:

March 13, 2018

Posting date:

April 13, 2018

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-66436

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  Reason
• 
  Affected products

Affected products

Xper Flex Cardio Physiomonitoring System-Main Unit

Reason

Philips has become aware that the real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue

Affected products