EPIQ DIAGNOSTIC ULTRASOUND SYSTEM 795232 (UDI 00884838097940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00884838097940), received between Sep 3, 2021 and Feb 13, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (5 reports).

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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Material Separation

  IT WAS REPORTED THAT THE X8-2T TRANSDUCER WAS PHYSICALLY DAMAGED RESULTING IN SEPARATION BETWEEN THE DISTAL TIP AND FLEXIBLE SHAFT. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVXI ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THERE WAS NO PATIENT OR USER WAS HARM AS A RESULT OF THE ISSUE. A PHILIPS REMOTE SERVICE ENGINEER INITIATED THE REPLACEMENT PROCESS TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335382 ↗
• MalfunctionJan 27, 2026Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED THE EPIQ CVXI ULTRASOUND SYSTEM DISPLAYED AN ERROR CODE DURING SURGERY IN THE CATH LAB. THE SURGERY WAS COMPLETED AFTER AN EXCHANGE OF THE ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE POWER REGULATOR WAS REPLACED TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188531 ↗
• MalfunctionJul 18, 2025Electrical /Electronic Property Problem; Material Integrity Problem; Electrical /Electronic Property Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TRANSESOPHAGEAL X8-2T TRANSDUCER HAD STRAIN RELIEF DAMAGE ON THE CABLE AND FAILED ELECTRICAL SAFETY TESTING. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVXI ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE, DURING THE TRANSDUCER CLEANING PROCESS. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A REPLACEMENT X8-2T TRANSDUCER WAS SENT TO THE CUSTOMER TO RESOLVE THEIR IMMEDIATE CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543108 ↗
• MalfunctionJun 27, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE EPIQ CVXI ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE IN THE OPERATING ROOM. THE SYSTEM LOCKED UP WITH AN ERROR CODE WHILE USING THE X8-2T TRANSDUCER. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER THE SYSTEM WAS EXCHANGED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER DETERMINED THE ISSUE WAS DUE TO A BAD CONNECTION. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347462 ↗
• MalfunctionFeb 28, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT A CUSTOMER¿S EPIQ CVXI ULTRASOUND SYSTEM SHUTDOWN MULTIPLE TIMES DURING AN UNKNOWN PROCEDURE IN THE CATHLAB. THE SYSTEM WAS REBOOTED MULTIPLE TIMES IN AN ATTEMPT TO REGAIN FUNCTIONALITY. THE USER DECIDED TO EXCHANGE THE ULTRASOUND SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SYSTEM¿S E-BOX AND ENTIRE ECHONAV COMPONENTS AND CABLING WERE REPLACED IN THE SYSTEM TO RESOLVE THE IMMEDIATE ISSUE. PHILIPS HAS STARTED AN INVESTIGATION AND UPON COMPLETION A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21490227 ↗
• MalfunctionAug 22, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED DURING A HEART VALVE PROCEDURE, THE EPIQ CVXI ULTRASOUND DISPLAYED ERROR CODE 251. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER THE SYSTEM WAS EXCHANGED AND THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043846 ↗
• MalfunctionJun 27, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THE EPIQ 5 ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. DURING A TRANSCATHETER EDGE TO EDGE REPAIR (TEER), A MITRAL VALVE REPAIR PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION IN THE LEFT ATRIUM. WHILE OBSERVING AND EVALUATING THE PERICARDIAL EFFUSION USING THE EPIQ SYSTEM AND A TEE, THE EPIQ CRASHED. THE SYSTEM WAS RESTARTED, AND IT TOOK ABOUT 10 MINUTES BEFORE IMAGING WAS AVAILABLE. THE PATIENT HAD A STERNOTOMY FOR THE PERICARDIAL EFFUSION AND THE OUTCOME WAS POSITIVE. THE EPIQ SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PERICARDIAL EFFUSION. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623959 ↗
• MalfunctionFeb 15, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE LOCK MECHANISM OF THEIR EPIQ CVXI ULTRASOUND SYSTEM¿S CONTROL PANEL IS BROKEN. THE ISSUE WAS DISCOVERED WHILE TRYING TO MOVE THE UNIT WITHIN THE USER FACILITY AND IT SWIVELED OUT. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER REPAIRED THE SYSTEM BY POSITIONING THE BEARING BACK INTO POSITION , ALLOWING THE SOLENOID TO LOCK INTO POSITION AND THE SYSTEM HAS BEEN RETURNED TO USE. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS CAUSED BY A HARDWARE ISSUE IN THE LATCHING MECHANISM OF THE ARTICULATING ARM WHICH PREVENTED THE LOCKING SOLENOID FROM FULLY ENGAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711649 ↗
• MalfunctionDec 8, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THE EPIQ CVXI ULTRASOUND SYSTEM DISPLAYED AN ERROR DURING USE AND THEN WHEN THE USER ATTEMPTED TO SWITCH PROBES, THE SYSTEM SHUT OFF. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY WERE UNSUCCESSFUL. OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT WILL BE REPORTED. THERE WAS NO HARM ASSOCIATED WITH THIS EVENT. THE SERVICE ENGINEER EVALUATED THE EQUIPMENT AND REPLACED THE X8-2T TRANSDUCER TO RESOLVE THE ISSUE. THE PROBE CAUSED AN ERROR WHEN CONNECTED TO THE SYSTEM. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT. 3019216-2023-00174 MFR REPORT NUMBER FOR INITIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292308 ↗
• MalfunctionJun 6, 2023No Apparent Adverse Event; Patient Data Problem; No Apparent Adverse Event; Patient Data Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A PATIENT¿S DATA WAS MIXED WITH ANOTHER EXAM WHILE USING THEIR EPIQ ULTRASOUND SYSTEM. ACCORDING TO THE CUSTOMER, IMAGES WERE BEING ADDED TO THE WRONG PATIENT STUDY. THE USER IDENTIFIED THE DATA MIX-UP, AND THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOMES AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075518 ↗
• InjuryMar 16, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE SYSTEM SHUT DOWN DURING A TEE PROCEDURE WHEN USING THEIR EPIQ CVXI ULTRASOUND SYSTEM. THE TEE PROCEDURE HAD TO BEEN CONTINUED WITH ANOTHER TEE PROBE. THE PATIENT WAS TRANSPORTED TO PACU FOR RECOVERY AND STABILIZATION. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

  Patient problems: Hypoxia

  MAUDE report 16553700 ↗
• MalfunctionAug 31, 2022Unexpected Shutdown; Unexpected Shutdown

  A CUSTOMER REPORTED THEIR EPIQ CVXI ULTRASOUND SYSTEM SHUT DOWN UNEXPECTEDLY DURING A CARDIAC MITRAL VALVE PROCEDURE. THE PROCEDURE IN PROGRESS WAS COMPLETED SUCCESSFULLY USING A DIFFERENT ULTRASOUND SYSTEM AVAILABLE AT THE CUSTOMER SITE. THERE WAS NO HARM OR ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331940 ↗
• MalfunctionJul 18, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED AN EPIQ CVXI ULTRASOUND SYSTEM USING AN X8-2T TRANSDUCER SHUT DOWN AND THE DISPLAY WENT BLACK DURING A HEART PROCEDURE. THEY WERE UNABLE TO REBOOT THE SYSTEM AND ANOTHER ULTRASOUND SYSTEM WAS BROUGHT IN TO COMPLETE THE PROCEDURE USING THE SAME TRANSDUCER. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15044438 ↗
• MalfunctionApr 25, 2022Image Display Error/Artifact; Image Display Error/Artifact

  A CUSTOMER REPORTED THEIR EPIQ CVXI ULTRASOUND SYSTEM WOULD NOT RECOGNIZE A TRANSDUCER ON THREE OF THE FOUR PORTS AND PRODUCED IMAGE ARTIFACTS FROM THE FUNCTIONAL PORT DURING AORTIC HEART VALVE REPLACEMENT SURGERY. THE SURGERY WAS UNABLE TO BE COMPLETED USING THE SUSPECT TRANSDUCER AND SYSTEM. REPAIR OF THE SYSTEM AND INVESTIGATION INTO THE PATIENT OUTCOME ARE CURRENTLY UNDER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194021 ↗
• MalfunctionDec 16, 2021Unexpected Shutdown; Unexpected Shutdown

  A CUSTOMER REPORTED THEIR EPIQ CVXI ULTRASOUND SYSTEM SHUT DOWN IN ECHO NAVIGATOR MODE DURING A MITRA CLIP HEART VALVE PROCEDURE. THE PROCEDURE IN PROGRESS WAS COMPLETED SUCCESSFULLY WITHOUT IMPACTING PATIENT OUTCOME. THE PATIENT WAS NOT HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019319 ↗
• MalfunctionDec 13, 2021No Device Output; Unexpected Shutdown; No Device Output; Unexpected Shutdown

  A CUSTOMER REPORTED THEIR EPIQ CVXI ULTRASOUND SYSTEM SHUT DOWN UNEXPECTEDLY DURING AN OPEN HEART PROCEDURE. THE PROCEDURE IN PROGRESS WAS COMPLETED SUCCESSFULLY USING THE SAME ULTRASOUND SYSTEM AFTER A SYSTEM RESTART. A PHILIPS SERVICE ENGINEER REPLACED THE POWER REGULATOR BOARD AND ORDERED UPDATED SOFTWARE TO RESOLVE THE IMMEDIATE ISSUE. THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983940 ↗
• MalfunctionSep 8, 2021Output Problem; Output Problem

  A CUSTOMER REPORTED AN EPIQ CVXI ULTRASOUND SYSTEM WOULD NOT CAPTURE ECG WAVEFORMS DURING AN INTERVENTIONAL SURGERY. THE PROCEDURE IN PROGRESS WAS COMPLETED SUCCESSFULLY AFTER RESTARTING THE SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443394 ↗
• MalfunctionSep 3, 2021Output Problem; Output Problem

  A CUSTOMER REPORTED AN EPIQ CVXI ULTRASOUND SYSTEM¿S TOUCH PANEL BECAME UNRESPONSIVE AND NO 2D IMAGE WAS DISPLAYED DURING A CARDIAC PROCEDURE. THE PROCEDURE IN PROGRESS WAS COMPLETED SUCCESSFULLY AFTER SWITCHING TRANSDUCER CONNECTORS AND REBOOTING THE SYSTEM. A PHILIPS FIELD SERVICE ENGINEER REPLACED THE SYSTEM HARD DRIVES AND UPDATED THE SYSTEM SOFTWARE TO RESOLVE THIS ISSUE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425036 ↗