Xper Flex Cardio Physiomonitoring System-Main Unit (2018-11-18)

Starting date:

November 18, 2018

Posting date:

November 30, 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-68468

• Reason
• Affected products

Affected products

Xper Flex Cardio Physiomonitoring System-Main Unit

Reason

Philips has become aware of the following issues:
1. Real time ECG and pressure waveform anomaly: under certain conditions, real time waveforms may not be accurately plotted or displayed. This problem is related to the display of waveforms only, and all numeric data including Invasive Blood Pressure (IBP), NIBP, Respiratory Rate, and End Tidal CO2 are correct. Should this occur during the plotting of an ECG QRS complex on the ECG channel, the r wave may be shortened or missing or the QRS complex may appear slightly broader. A pressure or other phasic waveform may appear to have a "notch" or a "flattened" appearance.
2. SPO2 measurement may not update on the display: the oxygen saturation (SPO2) numeric value displayed on the device may freeze, resulting in the display of measurements that are not current.
3. NIBP measurement may not update on the display: in auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the Non-Invasive Blood Pressure (NIBP) numeric value displayed on the device would not update, resulting in the display of measurements that are not current.

Affected products