Xper Flex Cardio Physiomonitoring System FC 2010 (REF 453564483321)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00884838083523), received between Nov 19, 2018 and Mar 31, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 15, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT VITALS FROM THE FC2010 DEVICE ARE FREEZING UNTIL REBOOT. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010489 ↗
• MalfunctionOct 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE ECG WAVEFORM IS STUCK. THIS HAS BEEN INTERPRETED TO MEAN THAT THE ECG WAVEFORM IS FROZEN, STALE OR NOT UPDATING AS EXPECTED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12650875 ↗
• MalfunctionOct 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INITIALLY REPORTED THAT THE MACHINE IS HANGING AND THE ECG LEADS ARE NOT FUNCTIONING PROPERLY. ONSITE SUPPORT WAS DISPATCHED TO FURTHER EVALUATE THE DEVICE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626531 ↗
• MalfunctionApr 22, 2021Electrical /Electronic Property Problem; Date/Time-Related Software Problem

  THE CUSTOMER REPORTED THAT THE HOST AND FLEX CARDIO BOOM SCREENS HAVE DIFFERENT TIMES AND ALSO ARE NOT ALWAYS IN SYNC. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711735 ↗
• MalfunctionApr 22, 2021Therapeutic or Diagnostic Output Failure

  THE CUSTOMER REPORTED A PROBLEM WITH THE XIM FLEX SWEEP SPEED. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11711435 ↗
• MalfunctionApr 2, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE WAVEFORMS ON THE BOOM MONITOR FREEZE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609551 ↗
• MalfunctionAug 24, 2020Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER STATED THAT THERE IS A PROBLEM WITH MEASUREMENT OF ECG OR BLOOD PRESSURE INTERMITTENTLY. THE SCANNING SPEED (SWEEP SPEED) AS WELL AS THE HEART RATE CALCULATED AS A FUNCTION OF THE ECG WERE INCORRECT. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442019 ↗
• MalfunctionAug 14, 2020Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED "SWEEP SPEED CHANGES". THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408514 ↗
• MalfunctionAug 14, 2020Intermittent Continuity

  THE CUSTOMER REPORTED THAT THE LIVE PORTION OF THE SYSTEM PAUSES FOR A SECOND, THEN THE SWEEP SPEED CHANGES FROM 25 TO 100. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408418 ↗
• MalfunctionAug 14, 2020Therapeutic or Diagnostic Output Failure

  THE CUSTOMER REPORTED THAT THE LIVE PORTION OF THE SYSTEM PAUSES FOR A SECOND, THEN THE SWEEP SPEED CHANGES FROM 25 TO 100. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408365 ↗
• MalfunctionJul 24, 2020Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYS 2 DIFFERENT HEART FREQUENCIES, AND THERE IS A DIFFERENCE BETWEEN THE LIVE IMAGE AND PLAYBACK WORKSTATION. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321397 ↗
• MalfunctionJul 1, 2020Operating System Becomes Nonfunctional

  THE CUSTOMER REPORTED THAT ONE SINGLE BASELINE IS STUCK ON THE SYSTEM, AND IS NOT GOOD QUALITY. 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 10217224 ↗
• MalfunctionNov 19, 2019Defective Device

  THE CUSTOMER REPORTED THAT THE TIME IS OFF BY 5 MINUTES WHEN SYNCHING. IT WAS REPORTED BY THE CUSTOMER THAT, THEY ARE NOTICING THE WAVES ARE NOT SYNCHING UP FROM THE BOOM TO THE CONTROL ROOM, AND IT APPEARS TO BE ABOUT 5 MINUTES OF A DIFFERENCE. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9344928 ↗
• MalfunctionJul 25, 2019Output Problem

  THE CUSTOMER REPORTED THAT, "THE POLIGRAFO CONTINUES TO SEND A DIFFERENT TRACK FROM THE MONITORED TO THE ROOM SCREEN RESPECTING TO WHAT APPEARS ON THE MONITORS IN THE AREA OF THE OUTDOOR SHIELDING ROOM". THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826426 ↗
• MalfunctionJul 21, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INCORRECT TRACK READINGS. IT WAS REPORTED BY THE CUSTOMER THAT, THE ECG SIGNALS ARE REGULAR, WHILE ON THE MONITOR OF THE POLYGRAPH IN THE CONTROL ROOM, THEY ARE IRREGULAR WITH BREAKS NOT CORRESPONDING TO REALITY (DROPPED QRS). THE DEVICE WAS IN CLINICAL USE.THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8810036 ↗
• MalfunctionNov 19, 2018Unable to Obtain Readings

  THE CUSTOMER REPORTED THE SPO2 IS NOT GIVING A READING, THE SPO2 REMAINS AT 0%. 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 Known Impact Or Consequence To Patient

  MAUDE report 8085331 ↗