Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2010 REV CRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00884838084902), received between Nov 13, 2018 and Oct 5, 2022 — classified as 1 death, 6 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

2 FDA recall records 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

1. 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 ↗

2. Mar 14, 2018Class IITerminated

   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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED HAVING INTERMITTENT MONITORING ISSUES IN ALL ROOMS. ACCORDING TO THE CUSTOMER, USERS ARE EXPERIENCING INTERMITTENT ISSUES WITH MONITORING OFF ERROR MESSAGES AND THE ECG IS NOT MATCHING THE BOOM MONITOR. IT WAS FURTHER STATED BY THE CUSTOMER THAT ISSUES HAVE BEEN HAPPENING SINCE THEIR UPGRADE FROM SOFTWARE VERSION 2.2 TO 2.6 AND WHEN ALL DEVICES WERE CHANGED TO WINDOWS 10. THIS CASE WILL ADDRESS THE ECG ISSUE. THE DEVICE DID NOT BEHAVE AS EXPECTED BY THE CUSTOMER. TO RESOLVE THE ISSUE, THE ATTENDING FSE REIMAGED THE DEVICE. 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 15546736 ↗
• MalfunctionAug 16, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED IS DIFFERENT FROM THE FC2010 DEVICE AND XDS. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234704 ↗
• InjuryMay 25, 2022Defibrillation/Stimulation Problem; Measurement System Incompatibility; Defibrillation/Stimulation Problem; Measurement System Incompatibility

  THE CUSTOMER REPORTED THAT THE EKG GOES FLAT WHEN USING A DEFIBRILLATOR. CUSTOMER IS REQUESTING ONSITE SUPPORT TO FURTHER EVALUATE THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT. FURTHER INFORMATION AS HAS BEEN REQUESTED ON PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 14495139 ↗
• InjuryMay 24, 2022Defibrillation/Stimulation Problem; Measurement System Incompatibility; Defibrillation/Stimulation Problem; Measurement System Incompatibility

  THE CUSTOMER REPORTED THAT THE EKG GOES FLAT WHEN USING A DEFIBRILLATOR. CUSTOMER IS REQUESTING ONSITE SUPPORT TO FURTHER EVALUATE THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 14492707 ↗
• InjuryMay 23, 2022Defibrillation/Stimulation Problem; Measurement System Incompatibility; Defibrillation/Stimulation Problem; Measurement System Incompatibility

  THE CUSTOMER REPORTED THAT THE EKG GOES FLAT WHEN USING A DEFIBRILLATOR. ACCORDING TO THE CUSTOMER, THEY REPLACED THE ECG TRUNK CABLE AND LEADS WITHOUT RESOLVE. CUSTOMER IS REQUESTING ONSITE SUPPORT TO FURTHER EVALUATE THE DEVICE. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14476156 ↗
• DeathApr 5, 2022No Display/Image; Adverse Event Without Identified Device or Use Problem; No Display/Image; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY HAD A VERY SICK PATIENT COME INTO THE LAB THAT THEY HAD TO DO CPR ON. STAFF USED THE DEFIBRILLATOR AND WHEN THEY DID THE FIRST SHOCK, THE FC2010 DEVICE WENT BLANK ON THE BOOM AND CONTROL ROOM (HOST) SHOWED AN OFF MESSAGE. THE PATIENT DIED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 14013342 ↗
• MalfunctionMar 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE HEART RATE DOES NOT MATCH THE DISPLAYED ECG CURVE (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 13861782 ↗
• MalfunctionFeb 11, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE FLEX CARDIO 2010 DEVICE IS HAVING ISSUES WHEN DISPLAYING VITALS DURING CASES. ACCORDING TO THE CUSTOMER, VITALS ARE SKIPPING OR REPEATING. 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 13513964 ↗
• MalfunctionFeb 7, 2022Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE NIBP (NON-INVASIVE BLOOD PRESSURE) IS NOT TURNING OFF AT TIMES. ADDITIONAL INFORMATION RECEIVED INDICATED THAT, THE CUFF WOULD INFLATE BUT NOT DEFLATE AND COMPLETE THE NORMAL CYCLE. 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 13471620 ↗
• MalfunctionJan 21, 2022Defibrillation/Stimulation Problem; Application Program Freezes or Fails to Launch; Defibrillation/Stimulation Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT DURING AN ELECTRO CARDIO VERSION IN THE CONTEXT OF A PULMONARY VEIN ISOLATION, A TOTAL FAILURE OF THE HEMODYNAMICS UNIT OCCURRED. ACCORDING TO THE CUSTOMER, THERE WAS NO ECG, NO BLOOD PRESSURE, AND SATURATIONS COULD NOT BE DERIVED FOR SEVERAL MINUTES. THE HEMODYNAMIC MODULE HAD TO BE SWITCHED OFF AND ON AGAIN (REBOOTED). THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314026 ↗
• MalfunctionJan 20, 2022Defibrillation/Stimulation Problem; Application Program Freezes or Fails to Launch; Defibrillation/Stimulation Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT DURING AN EMERGENCY CARE OF A POSTERIOR WALL INFARCTION WITH CARDIOPULMONARY RESUSCITATION AND MULTIPLE SHOCK DELIVERIES IN THE CARDIAC CATHETERIZATION LABORATORY, A TOTAL FAILURE OF THE HEMODYNAMIC UNIT OCCURRED. ACCORDING TO THE CUSTOMER, THERE WAS NO ECG, NO BLOOD PRESSURE, AND SATURATIONS COULD NOT BE DERIVED FOR SEVERAL MINUTES. THE HEMODYNAMIC MODULE HAD TO BE SWITCHED OFF AND ON AGAIN (REBOOTED). THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13307567 ↗
• InjuryJan 5, 2022Electrical /Electronic Property Problem; Application Program Problem; Electrical /Electronic Property Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT THE PATIENT WENT INTO ASYSTOLE DURING A PACEMAKER CAUTERIZING CASE WHERE THE EKG READ FLAT LINES.

  Patient problems: Asystole

  MAUDE report 13168645 ↗
• MalfunctionDec 16, 2021Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT SINCE THEIR FCO (FIELD CHANGE ORDER), THEY HAVE HAD ISSUES WITH SWEEP SPEED BEING DIFFERENT ON THE BOOM AND HOST, WHERE THEY DO NOT MATCH. THERE WAS NO REPORTED PATIENT OR USER IMPACT / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020313 ↗
• InjuryNov 24, 2021Defibrillation/Stimulation Problem; Insufficient Device Problem Information; Defibrillation/Stimulation Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT AFTER SHOCKING A PATIENT, THE ECG FLATLINES DURING BOVIE OR DEFIB USE.

  Patient problems: Insufficient Information

  MAUDE report 12869353 ↗
• MalfunctionOct 18, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT PRESSURE CHANNEL 1 (P1) IS LOCKING UP MID-CASE AND USERS HAVE TO REBOOT THE DEVICE TO CONTINUE. 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 12650822 ↗
• InjuryJul 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (V-FIB.) WHEN THE EKG WENT FLAT LINE EVEN THOUGH THE PATIENT WAS NOT FLAT LINE. STAFF USED A DEFIBRILLATOR TO GET THE HEART RATE BACK TO NORMAL. THERE WAS NO LASTING IMPACT TO THE PATIENT REPORTED AS A RESULT OF THIS ISSUE. THE DEVICE WAS IN USE AND THE PATIENT WENT INTO V-FIB.

  Patient problems: Ventricular Fibrillation

  MAUDE report 12225469 ↗
• MalfunctionJul 21, 2021Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED AUTOMATICALLY CHANGES AFTER THE IMPLEMENTATION OF FIELD CHANGE ORDER, FCO72200480. 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 12204313 ↗
• MalfunctionJul 20, 2021Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED AUTOMATICALLY CHANGES AFTER IMPLEMENTATION. 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 12199821 ↗
• MalfunctionJul 16, 2021Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED AUTOMATICALLY CHANGES AFTER THE IMPLEMENTATION OF FIELD CHANGE ORDER, (B)(4). 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 12180270 ↗
• MalfunctionJul 14, 2021No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE DEVICE HAS A NO SOUND ERROR ON THE XIMS DISPLAY. 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 12166130 ↗
• MalfunctionJul 9, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  THE CUSTOMER REPORTED THAT THE DEVICE IS LOCKING UP AFTER THE FCO UPGRADE. 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 12141682 ↗
• MalfunctionApr 23, 2021Device Markings/Labelling Problem

  THE CUSTOMER REPORTED THAT THE DEVICE IS SET AT 25 AND IS SHOWING 50. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715245 ↗
• MalfunctionApr 19, 2021Device Displays Incorrect Message

  THE CUSTOMER REPORTED THAT THE MONITOR DID NOT DISPLAY CORRECTLY. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11686306 ↗
• MalfunctionApr 19, 2021Device Displays Incorrect Message

  THE CUSTOMER REPORTED THAT THE MONITOR IS NOT DISPLAYING CORRECTLY. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11686300 ↗
• MalfunctionDec 23, 2020Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE SWEEP SPEED CHANGES BY ITSELF. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066180 ↗