Xper Flex Cardio Physiomonitoring System Xper Flex Cardio 2020 Rev D ExchangeRecalls & reported problems
Philips Ds North America LLC · Xper Flex Cardio 2020 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838086012), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Read Input Signal” (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
- Failure to Read Input Signal1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 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.
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