Xper Flex Cardio Physiomonitoring System Xper FC2010 Rev D EXCHANGERecalls & reported problems
Philips Ds North America LLC · Xper FC2010 Rev D 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
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838091474), received between May 10, 2024 and Nov 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Sep 24, 2018Class IICompleted
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 ↗
Most reported problems
Device problems
- Application Program Freezes or Fails to Launch1
- No Audible Prompt/Feedback1
- Operating System Becomes Nonfunctional1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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