Xper Flex Cardio Physiomonitoring System FC 2010 (REF 453564621791)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00884838084926), received between Jan 20, 2019 and Oct 21, 2024 — classified as 3 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE FC2010 WAS NOT ALARMING. THE VIDEO OUTPUT IS SHOWING ALARMS, BUT NO SOUND IS COMING OUT. 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 20494841 ↗
• MalfunctionOct 10, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE XPER FLEX CARDIO 2010 REV-C-EXCHANGE INDICATING THERE WAS NO AUDIO. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419306 ↗
• MalfunctionOct 3, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED IS CHANGING INTERMITTENTLY AND THERE IS A DIFFERENCE BETWEEN THE 2 MONITORS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859949 ↗
• MalfunctionJul 25, 2023Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED IS VERY FAST. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390216 ↗
• MalfunctionJul 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON THE XPER FLEX CARDIO 2010 REV-C-EXCHANGE INDICATING THAT THE SWEEP SPEED ON THE BOOM MONITOR WAS DISPLAYING FASTER THAN ON THE HOST. THE CUSTOMER STATES THAT A DEVICE RESTART RESOLVES THE ISSUE. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY, NO REPORT OF MISINTERPRETATION OR MISDIAGNOSIS, NOR WAS THERE A REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269036 ↗
• MalfunctionNov 10, 2022Thermal Decomposition of Device; Sparking

  IT WAS REPORTED THAT THE POWER SUPPLY HAD AN ELECTRICAL BURN AND PRODUCED SPARKS BETWEEN THE POWER SUPPLY AND POWER CABLE. WHEN PHILIPS WENT ONSITE, FOUND THAT THE CUSTOMER HAD ALREADY ISOLATED THE CABLE AT BOTH ENDS AND REMOVED THE POWER SUPPLY FROM THE THEATRE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE OCCURRED. THERE AS NO ADVERSE EVENT OR USER/PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775446 ↗
• MalfunctionOct 11, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT ARTIFACTS ARE APPEARING IN ECG AND AUDIO ALARM IS NOT COMING. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE FSE EVALUATED THE DEVICE AND DETERMINED THAT THE AUDIO ERROR WAS NOT PRESENT AT THE TIME OF INSPECTION, AND THAT THE AUDIO VOLUME WAS VERY LOW. THE FSE RESEATED THE DEVICE SPEAKERS AND CONFIRMED THAT THE DEVICE AUDIO IS NOW FUNCTIONING AS EXPECTED. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578090 ↗
• MalfunctionSep 12, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED HAVING INTERMITTENT MONITORING ISSUES IN ALL ROOMS, INTERMITTENT OFF OR ECG NOT MATCHING THE BOOM. IT WAS CONFIRMED THERE AS NO ISSUE WITH THE MONITORING OFF, THE ISSUE WAS THE ECG SWEEP SPEED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406322 ↗
• MalfunctionSep 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT IT LOOKS LIKE THE SWEEP SPEED CHANGES ON THE MONITOR. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375439 ↗
• MalfunctionSep 7, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED HAVING INTERMITTENT MONITORING ISSUES IN ALL ROOMS. INTERMITTENT OFF OR ECG NOT MATCHING THE BOOM. THE DEVICE WAS IN USE. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371198 ↗
• MalfunctionAug 9, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED SLOWNESS IN THE DISPLAY OF THE PLOTS (SWEEP SPEED). 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 15191662 ↗
• MalfunctionJun 10, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE WAVE TRACING APPEARS TO BE STRETCHED WHEN DISPLAYING ON FLEXVISION. 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 14652624 ↗
• MalfunctionApr 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE LIVE SPEED (SWEEP SPEED) ON THE MONITOR IN THE EXAMINATION ROOM IS DIFFERENT FROM THAT IN THE CONTROL ROOM. 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 13994322 ↗
• MalfunctionMar 24, 2022Defibrillation/Stimulation Problem; Insufficient Device Problem Information; Defibrillation/Stimulation Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE PATIENT WAS DECLINING DURING CASE AND WAS DEFIBRILLATED, WHICH IN TURN CAUSED THE EKG TO FLAT LINE AND PRESSURES TO DISAPPEAR. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION REGARDING THIS INCIDENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892896 ↗
• InjuryMar 21, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION EXAMINATION OF A PATIENT UNDER GENERAL ANESTHESIA, THE PATIENT HAD TO BE REANIMATED IN THE PROCEDURE, AND THE HEMO MONITORING WAS FROZEN. ACCORDING TO THE CUSTOMER, THERE WAS NO LIVE ECG MONITORING IN EITHER THE EXAMINATION ROOM OR IN THE CONTROL ROOM. REBOOTING THE BOX FIXED THE PROBLEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839941 ↗
• MalfunctionJan 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE DEVICE SHOWS THE NON-INVASIVE BLOOD PRESSURE READING FROM THE PREVIOUS PATIENT. 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 13329168 ↗
• MalfunctionDec 9, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT HEMOS LOCKED UP. 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 12968015 ↗
• MalfunctionDec 8, 2021Output Problem; Application Program Freezes or Fails to Launch; Output Problem; Application Program Freezes or Fails to Launch

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964367 ↗
• MalfunctionDec 1, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT HEMO'S FROZE. ADDITIONAL INFORMATION RECEIVED FROM REMOTE SUPPORT ENGINEER (RSE), WHO INDICATED THAT, THE HEMO SCREEN FROZE, WAVES STOPPED MOVING, AND VALUES STOPPED CHANGING. 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 12907854 ↗
• MalfunctionNov 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE TRACE SPEED (SWEEP SPEED) IS DIFFERENT FROM THE CONTROL ROOM TO THE EXAMINATION ROOM. 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 12883148 ↗
• MalfunctionNov 22, 2021Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED ON THE BOOM APPEARS HIGHER THAN THE SWEEP SPEED IN THE CONTROL ROOM. THE HEART RATE READING IS NOT ACCURATE, THE ECG IS GETTING DRAGGED ONLY INSIDE THE LAB. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852481 ↗
• MalfunctionNov 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED CHANGES ON ITS OWN ON THE BOOM. 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 12827650 ↗
• MalfunctionOct 21, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE IR LAB WAS SEEING PAUSES WITH ECG FOR ONE CASE PERFORMED ON (B)(6), 2021.THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672673 ↗
• MalfunctionOct 19, 2021No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT NO SOUND AT ALL SEEMED TO BE COMING OUT OF THE DEVICE. IT IS UNKNOW IF THE DEVICE WAS IN USE AT TIME OF EVENT AND NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12660877 ↗
• MalfunctionOct 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED GOES FAST THEN SLOW. 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 12590265 ↗