Health product recall

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM (2021-04-01)

Starting date:
April 1, 2021
Posting date:
April 14, 2021
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-75387

Last updated:
2021-04-14

Affected Products 

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

Reason

Philips recently discovered several performance issues with the Xper Flex Cardio Physio Monitoring System. The issues include:

  1. A potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters on the boom monitor after the data is acquired.
  2. Displayed patient weight is rounded to the nearest whole kilogram.
  3. Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash, resulting in a loss of a visual display of waveforms and numerics on the displays driven by the Xper IM software, but the alarms and monitoring displays driven by the Xper Flex Cardio continue to function normally.
  4. No SpO2 numeric or plethysmography is displayed when SpO2 is connected to the Flex Cardio device.
  5. The display of certain data from the FC2010 becomes frozen, i.e., Waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric values cease to update.
  6. The ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP.
  7. Upon start up, an unexpected non physiological ECG waveform, erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor.

Affected products

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

Lot or serial number

All lots.

Model or catalog number

FC2010
FC2020

Companies
Manufacturer

Invivo, a Div. of Philips Medical Systems

12151 Research Parkway

Orlando

32826

Florida

UNITED STATES