EPIQ Diagnostic Ultrasound System 795232 (UDI 00884838114142)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838114142), received between Mar 26, 2025 and Dec 3, 2025 — classified as 2 deaths, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  A CUSTOMER REPORTED THEIR EPIQ CVXI ULTRASOUND SYSTEM CRASHED DURING A MITRAL CLIP TREATMENT. THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO USER OR PATIENT HARM AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER WAS NOT ABLE TO REPRODUCE THE REPORTED 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 23706885 ↗
• MalfunctionNov 4, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THE EPIQ CVXI ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) PROCEDURE WHILE CONNECTED TO AN EXTERNAL MONITOR. THE SYSTEM SHUT DOWN AND WAS REBOOTED SEVERAL TIMES. THERE WAS NO REPORTED PATIENT NOR USER HARM AS A RESULT OF THE ISSUE. A PHILIPS FIELD SERVICE ENGINEER ADVISED THE CUSTOMER TO PLUG IN THE EXTERNAL MONITOR WHILE THE SYSTEM IS OFF TO RESOLVE THE 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 23472700 ↗
• MalfunctionMay 28, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THE EPIQ CVXI ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL CORONARY PROCEDURE. THE SYSTEM CRASHED DURING THE PROCEDURE AND WAS UNABLE TO BE RECOVERED. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE. 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 22099784 ↗
• DeathMay 6, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE EPIQ CVXI ULTRASOUND SYSTEM BECAME UNRESPONSIVE AND LOCKED UP DURING AN EXAMINATION WHERE A PATIENT WAS CODING. THE CLINICIAN HAD TO BRING IN ANOTHER SYSTEM IN AN ATTEMPT TO COMPLETE THE EXAMINATION. UNFORTUNATELY, THE PATIENT DID NOT RECOVER FROM THE CODE AND ULTIMATELY EXPIRED; HOWEVER, THE CUSTOMER HAS CLEARLY STATED THE ULTRASOUND DID NOT CAUSE THE PATIENT INCIDENT. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Cardiac Arrest

  MAUDE report 21971899 ↗
• DeathMay 6, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE EPIQ CVXI ULTRASOUND SYSTEM BECAME UNRESPONSIVE AND LOCKED UP DURING AN EXAMINATION WHERE A PATIENT WAS CODING. THE CLINICIAN HAD TO BRING IN ANOTHER SYSTEM IN AN ATTEMPT TO COMPLETE THE EXAMINATION. UNFORTUNATELY, THE PATIENT DID NOT RECOVER FROM THE CODE AND ULTIMATELY EXPIRED; HOWEVER, THE CUSTOMER HAS CLEARLY STATED THE ULTRASOUND DID NOT CAUSE THE PATIENT INCIDENT. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Cardiac Arrest

  MAUDE report 21971231 ↗
• MalfunctionMar 26, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THE SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. THE EPIQ CVX ULTRASOUND SYSTEM SHUT DOWN MULTIPLE TIMES DURING AN UNSPECIFIED OPEN-HEART SURGERY. THE TRANSDUCER WAS EXCHANGED TO COMPLETE THE PROCEDURE. 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 21700902 ↗