Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2020 REV CRecalls & reported problems
Philips Ds North America LLC · Class 2
All models of Xper Flex Cardio Physiomonitoring System (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838084919), received between Oct 25, 2019 and Nov 4, 2021 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Application Program Problem” (1 report).
1 FDA recall record name this device's 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, 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.
Recalls naming this device
- Mar 29, 2021Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Application Program Problem1
- Defibrillation/Stimulation Problem1
- Device Alarm System1
- Self-Activation or Keying1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- No Known Impact Or Consequence To Patient3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2021Defibrillation/Stimulation Problem; Application Program Problem; Defibrillation/Stimulation Problem; Application Program Problem
THE CUSTOMER REPORTED THAT THE MONITORING SCREEN WENT BLANK AFTER SHOCKING (DEFIBRILLATING) A PATIENT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: Insufficient Information
MAUDE report 12753672 ↗MalfunctionMar 19, 2020Device Alarm System
THE CUSTOMER REPORTED ALARM ISSUE ON ALL BED SIDES. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9856062 ↗MalfunctionOct 29, 2019Self-Activation or Keying
THE CUSTOMER REPORTED THAT THE FLEX CARDIO SWEEP SPEED ON THE BOOM MONITOR ABRUPTLY CHANGES TO 400+ MM/SEC. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9249420 ↗MalfunctionOct 25, 2019Use of Incorrect Control/Treatment Settings
THE CUSTOMER REPORTED THAT THE FLEX CARDIO SWEEP SPEED ON THE BOOM MONITOR ABRUPTLY CHANGED TO 400+ MM/SEC. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9241444 ↗
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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