Xper Flex Cardio Physiomonitoring SystemRecalls & reported problems across all models

We found 19 models of Xper Flex Cardio Physiomonitoring System by Philips Ds North America LLC in the FDA's device registry (GUDID). Together they are named in 197 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2018 and Sep 23, 2026 — classified as 4 deaths, 15 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (31 reports).

3 FDA recall records name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Xper Flex Cardio Physiomonitoring System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 29, 2021Open, Classified

   Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; 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;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, 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

   Z-1517-2021 · Root cause: Software design · names 10 of these models · Recall details · FDA record ↗

2. Sep 24, 2018Completed

   The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard

   Z-0462-2019 · Root cause: Software Design Change · Recall details · FDA record ↗

3. Mar 14, 2018Terminated

   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.

   Z-1867-2018 · Root cause: Software design · names 6 of these models · Recall details · FDA record ↗

Most reported Xper Flex Cardio Physiomonitoring System problems

Xper Flex Cardio Physiomonitoring System models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2010 REV C

  MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
  2 recalls1 death42 reports
• Xper Flex Cardio Physiomonitoring System FC 2010

  MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
  2 recalls2 deaths38 reports
• Xper Flex Cardio Physiomonitoring System FC 2010

  MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
  1 recall50 reports
• Xper Flex Cardio Physiomonitoring System FC 2010

  MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
  1 recall19 reports
• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio 2010 Rev D

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 recall1 death13 reports
• Xper Flex Cardio Physiomonitoring System FC 2020

  MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
  1 recall6 reports
• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio 2010 Rev E

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 recall5 reports
• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2020 REV C

  MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
  1 recall4 reports
• Xper Flex Cardio Physiomonitoring System FC 2010

  MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
  1 recall2 reports
• Xper Flex Cardio Physiomonitoring System Xper FC2010 Rev D EXCHANGE

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 recall2 reports
• Xper Flex Cardio Physiomonitoring System FC 2020

  MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
  1 recall1 report
• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio 2020 Rev D

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 recall0 reports
• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2020 REV E

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 recall0 reports
• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2010 REV E Russian

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 recall0 reports
• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2010 REV C Russian

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 recall0 reports
• Xper Flex Cardio Physiomonitoring System FC2010

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  11 reports
• Xper Flex Cardio Physiomonitoring System Xper FC2010 Rev E EXCHANGE

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  2 reports
• Xper Flex Cardio Physiomonitoring System Xper Flex Cardio 2020 Rev D Exchange

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 report
• Xper Flex Cardio Physiomonitoring System FC2010

  Monitor, physiological, patient (without arrhythmia detection or alarms)
  1 report

Recent Xper Flex Cardio Physiomonitoring System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868930 ↗
• InjuryJun 17, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE DEVICE TIMED OUT AND THE PATIENT WENT INTO RESPIRATORY ARREST DURING A RESTART. THE CUSTOMER INDICATED THE CUSTOMER NOTICED THE ARREST WHEN THE PATIENT BECAME UNRESPONSIVE. ADDITIONAL INFORMATION WAS NOT PROVIDED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Respiratory Arrest

  MAUDE report 25530744 ↗
• MalfunctionMar 31, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON THE XPER FLEX CARDIO 2010 REV-B-EXCHANGE INDICATING THAT THE ECG DOES NOT HAVE A SMOOTH CURVE AND IS PIXELATED AND SQUARED OFF. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730474 ↗
• MalfunctionNov 1, 2024Operating System Becomes Nonfunctional; Application Program Freezes or Fails to Launch; Operating System Becomes Nonfunctional; Application Program Freezes or Fails to Launch

  IT WAS REPORTED, WHILE PERFORMING MEDICAL PROCEDURES, IT WAS NECESSARY TO PERFORM DEFIBRILLATION OF A PATIENT, AFTER PERFORMING THE DEFIBRILLATION, MONITORING OF THE PATIENT WAS IMPOSSIBLE DUE TO THE HEMO SYSTEM SUSPENSION. THE SYSTEM REQUIRED A RESTART. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586637 ↗
• MalfunctionOct 21, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE FC2010 WAS NOT ALARMING. THE VIDEO OUTPUT IS SHOWING ALARMS, BUT NO SOUND IS COMING OUT. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494841 ↗
• MalfunctionOct 10, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE XPER FLEX CARDIO 2010 REV-C-EXCHANGE INDICATING THERE WAS NO AUDIO. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419306 ↗
• MalfunctionMay 10, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE PULSE SOUND CAN NO LONGER BE HEARD IN THE CATHETER LAB. IT ONLY EXISTS ON THE MONITOR. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288889 ↗
• MalfunctionApr 12, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE GROUND FLOOR ELECTROCARDIOGRAM (ECG) SIGNAL WAS FROZEN DURING THE EXAMINATION. HOWEVER, THE PRESSURE CONTINUED TO RUN CORRECTLY. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096252 ↗
• MalfunctionOct 3, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED IS CHANGING INTERMITTENTLY AND THERE IS A DIFFERENCE BETWEEN THE 2 MONITORS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859949 ↗
• MalfunctionJul 25, 2023Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED IS VERY FAST. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390216 ↗
• MalfunctionJul 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON THE XPER FLEX CARDIO 2010 REV-C-EXCHANGE INDICATING THAT THE SWEEP SPEED ON THE BOOM MONITOR WAS DISPLAYING FASTER THAN ON THE HOST. THE CUSTOMER STATES THAT A DEVICE RESTART RESOLVES THE ISSUE. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY, NO REPORT OF MISINTERPRETATION OR MISDIAGNOSIS, NOR WAS THERE A REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269036 ↗
• MalfunctionMay 22, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) IMAGE ON THE FLEXVISION MONITOR FREEZES. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981586 ↗
• InjuryMay 10, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN IN THE MIDDLE OF PATIENT CODING, WOULD LIKE SOMEONE TO LOOK AT PATIENT LOGS. THE CUSTOMER INDICATED PATIENT HARM; HOWEVER, NO DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, PATIENT STATUS AND EVENT DETAILS ARE UNKNOWN. A PHILIPS REMOTE SERVICE ENGINEER (RSE) ASSISTED THE BIOMED WITH THE LOGS AND THERE WAS NO RELEVANT DEVICE DATA FOUND DURING THE TIME FRAME OF THE ALLEGED FAILURE. IN ADDITION, THE RSE IDENTIFIED THE DEVICE WAS NOT BEING SHUTDOWN IN ORDER TO PREVENT FAILURES DURING CASES AND THAT THERE HAS NOT BEEN ANY PREVENTATIVE MAINTENANCE (PM) PERFORMED ON DEVICES. THE CUSTOMER WAS PROVIDED WITH DOCUMENTATION ON THESE PROCEDURES SO THEY CAN PERFORM PM WORK, AND THE STAFF WAS INSTRUCTED THAT THESE DEVICES NEED TO BE SHUTDOWN AND RESTARTED DAILY BEFORE CASES ARE PERFORMED. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EVENT. THE EVENT DETAILS WERE REVIEWED BY A PHILIPS SR. PRODUCT SUPPORT ENGINEER WHO STATED THE LIKELY CAUSE OF THE EVENT IS THE FLEX CARDIO WAS OVER ENERGIZED PAST THE BOUNDS OF OUR SPECIFICATIONS.

  Patient problems: Cardiac Arrest

  MAUDE report 16904627 ↗
• InjuryApr 7, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN IN THE MIDDLE OF PATIENT CODING, WOULD LIKE SOMEONE TO LOOK AT PATIENT LOGS. THE CUSTOMER INDICATED PATIENT HARM; HOWEVER, NO DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, PATIENT STATUS AND EVENT DETAILS ARE UNKNOWN. A PHILIPS REMOTE SERVICE ENGINEER (RSE) ASSISTED THE BIOMED WITH THE LOGS AND THERE WAS NO RELEVANT DEVICE DATA FOUND DURING THE TIME FRAME OF THE ALLEGED FAILURE. IN ADDITION, THE RSE IDENTIFIED THE DEVICE WAS NOT BEING SHUTDOWN IN ORDER TO PREVENT FAILURES DURING CASES AND THAT THERE HAS NOT BEEN ANY PREVENTATIVE MAINTENANCE (PM) PERFORMED ON DEVICES. THE CUSTOMER WAS PROVIDED WITH DOCUMENTATION ON THESE PROCEDURES SO THEY CAN PERFORM PM WORK, AND THE STAFF WAS INSTRUCTED THAT THESE DEVICES NEED TO BE SHUTDOWN AND RESTARTED DAILY BEFORE CASES ARE PERFORMED. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EVENT. THE EVENT DETAILS WERE REVIEWED BY A PHILIPS SR. PRODUCT SUPPORT ENGINEER WHO STATED THE LIKELY CAUSE OF THE EVENT IS THE FLEX CARDIO WAS OVER ENERGIZED PAST THE BOUNDS OF OUR SPECIFICATIONS.

  Patient problems: Cardiac Arrest

  MAUDE report 16700356 ↗
• MalfunctionApr 7, 2023Failure to Read Input Signal; Failure to Read Input Signal

  THE CUSTOMER REPORTED THAT THE FC2010 STOPPED POPULATING VITALS DURING CASE WHILE PATIENT WAS CODING. THE CUSTOMER REPORTED ECG TRACING WAS NOT AVAILABLE, NO NON-INVASIVE MEASUREMENTS (BP, HR, SPO2), AND NO ARTERIAL TRACINGS WERE FUNCTIONAL AND DISPLAYED. THE FC2010 WAS NOT CONNECTED TO OTHER DEVICES. THE PATIENT CONTINUED TO BE APPROPRIATELY RESUSCITATED. THE IMPELLA (VENTRICULAR ASSIST DEVICE) WAS USED FOR THE PATIENT'S ARTERIAL TRACING. THIS DID NOT LEAD TO HARM TO THE PATIENT AS THE STAFF WAS ABLE TO SEE ARTERIAL TRACINGS USING THE IMPELLA DEVICE WHILE TROUBLESHOOTING THE FLEX CARDIO FOR THREE MINUTES. APPROPRIATE RESUSCITATION CONTINUED, BUT THE USER WAS MORE CONCERNED WITH PROPER DOCUMENTATION OF THE VITAL SIGNS WITH REGARD TO THE DEVICE ISSUE. THERE WAS NO INDICATION THIS ISSUE RESULTED IN ANY ADDITIONAL HARM TO THE PATIENT. A PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER TO EVALUATE THE DEVICE IN QUESTION. THE RSE PROVIDED THE CUSTOMER WITH THE FC2010 PREVENTIVE XPER IFU DOCUMENTATION TO CUSTOMER TO REVIEW. THE RSE RECOMMENDED, IF POSSIBLE, TO POWER DRAIN THE FC2010 TO RESTART THE FC2010\HEMO APP STATION DAILY, OR MONDAY MORNINGS, BEFORE EACH CASE. THE RSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16699847 ↗

Other Philips Ds North America LLC products

• Invivo19 models · 5 reports · 11 recalls