Xper Flex Cardio Physiomonitoring System Xper FC2010 Rev E EXCHANGERecalls & reported problems
Philips Ds North America LLC · Xper FC2010 Rev E EXCHANGE · Class 2
All models of Xper Flex Cardio Physiomonitoring System (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838093775), received between Sep 7, 2021 and Oct 6, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2022Output Problem
THE CUSTOMER REPORTED THAT DURING A CORONARY ANGIOGRAPHY WHILE MONITORING THE HEART RHYTHM OF A PATIENT, A BREAK OCCURRED AND LASTED 5 MINUTES. AFTER CHECKING THE CONNECTIONS TO THE PATIENT AND THE EQUIPMENT, THE ECG SIGNAL ONLY RESUMED AFTER THE BALLOON, WHICH IS USED TO MONITOR THE PATIENT'S VITAL PARAMETERS DURING THE EXAMINATION HAD BEEN SWITCHED OFF AND ON AGAIN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15550140 ↗MalfunctionSep 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED TO PHILIPS THAT, "THE INVASIVE BLOOD PRESSURE REAL TIME WAVEFORM WAS DISPLAYED CORRECTLY, BUT ITS NUMERICAL VALUES WERE NOT UPDATED. THE MALFUNCTION HAPPENED DURING AN URGENT CATH-LAB PROCEDURE. THE CUSTOMER NOTICED THAT THE INVASIVE PRESSURE WAS DECREASING ON THE DISPLAYED WAVEFORM, BUT THE PRESSURE NUMERICAL VALUES WERE FROZEN. THEY DID A SNAPSHOT AND IN THE SNAPSHOT THE PRESSURE NUMERICAL VALUES WERE CORRECTLY UPDATED AS EXPECTED. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12436437 ↗
Other Monitor, physiological, patient (without arrhythmia detection or alarms) devices
- Rad-97 9738Masimo Corporation · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1 death222 reports
- Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2010 REV CPhilips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls1 death42 reports
- Xper Flex Cardio Physiomonitoring System FC 2010Philips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 deaths38 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page