EPIQ Diagnostic Ultrasound System 795231 (UDI 00884838123960)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00884838123960), received between Dec 12, 2024 and Jun 3, 2026 — classified as 4 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (K233545, K233788, K240850, K240980, K251651); they may or may not involve this specific model.

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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE EPIQ CVX ULTRASOUND SYSTEM DISPLAYED AN ERROR MESSAGE AND SHUT DOWN DURING USE IN A CRITICAL ACUTE AORTIC DISSECTION PROCEDURE. NO FURTHER INFORMATION WAS RECEIVED. THE SYSTEM WAS EVALUATED BY THE BIOMEDICAL ENGINEER. THE REPORTED PROBLEM WAS NOT ABLE TO BE REPRODUCED AND THE SYSTEM WAS RETURNED TO SERVICE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 25380282 ↗
• InjuryJun 3, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE EPIQ CVX ULTRASOUND SYSTEM DISPLAYED AN ERROR MESSAGE AND SHUT DOWN DURING USE IN A CRITICAL ACUTE AORTIC DISSECTION PROCEDURE. THE SYSTEM WAS REBOOTED TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED NO PERMANENT HARM OCCURRED TO THE PATIENT; ANY HARM CAUSED BY THE DELAY IS NOT OBVIOUS OR DIFFICULT TO QUANTIFY. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 25377125 ↗
• MalfunctionMay 29, 2026Unintended Application Program Shut Down

  A CUSTOMER REPORTED THEIR EPIQ CVX ULTRASOUND SYSTEM SHUT DOWN IN THE THORACIC OPERATING THEATER. ADDITIONAL INFORMATION IS BEING GATHERED TO IDENTIFY THE DEVICE USE AT THE TIME OF THE EVENT AND THE PROCEDURE PERFORMED. THERE WAS NO USER OR PATIENT HARM REPORTED AS A RESULT OF 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 25339988 ↗
• MalfunctionMay 27, 2026Fitting Problem

  A CUSTOMER REPORTED THEIR EPIQ CVX ULTRASOUND SYSTEM RESPONDED POORLY WHEN CONNECTING AN UNSPECIFIED PROBE DURING A VALVE REPLACEMENT PROCEDURE. THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO USER OR PATIENT HARM AS A RESULT OF 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 25310621 ↗
• MalfunctionMay 14, 2026Unintended System Motion

  IT WAS REPORTED THAT THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY IN SWIVEL MODE WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS SERVICE ENGINEER WENT ON SITE AND WAS UNABLE TO REPLICATE THE ALLEGED CONDITION REPORTED BY THE CUSTOMER CONCLUDING THE CUSTOMER'S DEVICE WAS PERFORMING AS DESIGNED. A QUALIFIED SERVICE ENGINEER EVALUATED THE SYSTEM BASED ON THE CUSTOMER COMPLAINT. THE SERVICE ENGINEER WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE SYSTEM WAS RETURNED TO SERVICE WITH NO FURTHER SIMILAR ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173588 ↗
• MalfunctionApr 17, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS SERVICE ENGINEER REPAIRED THE SYSTEM BY ADJUSTING THE SOLENOID, WHICH ALLOWED THE LOCKING MECHANISM TO BE FULLY ENGAGED. 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 24911705 ↗
• InjuryMar 30, 2026Mechanical Jam

  THIS IS SUPPLEMENTAL REPORT ONLY, REF: MEDWATCH MW5185243. THIS EVENT HAS ALREADY BEEN REPORTED TO FDA, REF: MFR REPORT NUMBER 3019216-2026-100114.

  Patient problems: Insufficient Information

  MAUDE report 24708786 ↗
• MalfunctionMar 4, 2026Unintended Application Program Shut Down

  IT WAS REPORTED THE EPIQ CVX ULTRASOUND SYSTEM WAS NOT AVAILABLE TO PERFORM A URGENT ECHO EXAM. THE SYSTEM WAS DISPLAYING ERROR MESSAGE AND THE USER REBOOTED THE SYSTEM THREE TIMES WITHOUT RECOVERY. THE USER THEN EXCHANGED THE UNSPECIFIED TRANSDUCER TO RECOVER THE SYSTEM AND COMPLETE THE EXAM. THERE WAS NO REPORTED USER OR PATIENT HARM. 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 24505847 ↗
• MalfunctionFeb 10, 2026Poor Quality Image

  IT WAS REPORTED THAT DURING A CABG (CORONARY ARTERY BYPASS GRAFT) SURGICAL PROCEDURE, THE EPIQ CVX AND THE X8-2T TRANSDUCER WERE PRODUCING POOR QUALITY IMAGES. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SYSTEM AND THE TRANSDUCER WERE EXCHANGED TO COMPLETE THE PROCEDURE. THE SERVICE ENGINEER AND THE CUSTOMER CONFIRMED THE POOR-QUALITY IMAGES WERE CAUSED BY A SCRATCH ON THE LENS OF THE X8-2T TRANSDUCER. THE SERVICE ENGINEER HAS STARTED THE REPLACEMENT PROCESS 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 24304355 ↗
• MalfunctionFeb 5, 2026Unintended Application Program Shut Down

  IT WAS REPORTED A CUSTOMER¿S EPIQ CVX ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) IMAGING PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PHILIPS HAS STARTED AN INVESTIGATION, AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270855 ↗
• MalfunctionJan 12, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE EPIQ CVX ULTRASOUND SYSTEM GENERATED AN ON-SCREEN ERROR CODE DURING AN UNSPECIFIED EXAM REQUIRING THE USER HAVING TO RESTART THE SYSTEM. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME WHICH LED TO A DELAY, AND THEY WERE NOT ABLE TO FINISH THE PROCEDURE WITH THIS SYSTEM. THERE WAS NO REPORTED PATIENT OR USER HARM AS A RESULT OF THE ISSUE. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE EVENT DETAILS. 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 24049824 ↗
• MalfunctionJan 8, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRANSESOPHAGEAL X8-2T TRANSDUCER HAD A TORN OPEN SEAL AT THE NOSE, RESULTING IN EXPOSED METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A REPLACEMENT 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 24016729 ↗
• MalfunctionDec 17, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE EPIQ CVX ULTRASOUND SYSTEM, BEING USED WITH AN X8-2T TRANSDUCER, WAS NOT AVAILABLE FOR USE DURING AN UNSPECIFIED CARDIAC SURGERY. THE SYSTEM DISPLAYED AN ERROR MESSAGE AND WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER DETERMINED THAT THE X8-2T TRANSDUCER WAS CAUSING THE REPORTED ISSUE AND REPLACED THE TRANSDUCER 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 23831001 ↗
• MalfunctionDec 11, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED THEIR EPIQ CVX ULTRASOUND SYSTEM LOCKED UP DURING CARDIAC SURGERY, AND PROCEEDED TO LOCK UP AGAIN AFTER RESTARTING THE SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. A QUALIFIED FIELD SERVICE ENGINEER EVALUATED THE SYSTEM BASED ON THE CUSTOMER¿S COMPLAINT AND COULD NOT REPRODUCE THE ISSUE. LOG REVIEW INDICATED DIRTY CONNECTORS WERE FOUND, SO THE TRANSDUCER CONNECTOR WAS CLEANED TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERN. 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 23776610 ↗
• MalfunctionNov 6, 2025Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED THEIR X8-2T TRANSDUCER HAD ARTICULATION ISSUES DURING CLINICAL USE. THE CUSTOMER WAS UNABLE TO USE THE TRANSDUCER, SO ANOTHER DEVICE WAS USED TO COMPLETE THE EXAM. A PROBE REPLACEMENT WAS SHIPPED TO THE CUSTOMER TO RESOLVE THEIR IMMEDIATE CONCERNS. 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 23487347 ↗
• MalfunctionNov 5, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED THAT THEIR EPIQ CVX ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL HEART VALVE PROCEDURE. THE SYSTEM GENERATED AN ERROR CODE, AND THE ISSUE PERSISTED AFTER A REBOOT. THE PROCEDURE WAS ABLE TO BE COMPLETED. THERE WAS NO PATIENT OR USER HARM AS A RESULT OF THE ISSUE. A PHILIPS FIELD SERVICE ENGINEER REPLACED THE SSD (SOLID-STATE DRIVE) AND RELOADED THE SYSTEM SOFTWARE 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 23481872 ↗
• MalfunctionOct 30, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED A 005-ERROR MESSAGE OCCURRED WHEN USING A TEE PROBE WITH THEIR EPIQ CVX ULTRASOUND SYSTEM DURING A CARDIAC PROCEDURE. THE ULTRASOUND SYSTEM AND TRANSDUCER WERE EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARMED AS A RESULT OF 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 23427233 ↗
• MalfunctionOct 20, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER VERIFIED THE REPORTED ISSUE. THE SERVICE ENGINEER REPLACED THE SOLENOID AND THE BEARING 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 23337225 ↗
• MalfunctionOct 20, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE X8-2T TRANSDUCER WAS NOT ARTICULATING PROPERLY DURING USE. THE TRANSDUCER IS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED USING THE SAME TRANSDUCER. 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 23335213 ↗
• MalfunctionOct 17, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED A 005-ERROR MESSAGE OCCURRED WHEN USING A TEE PROBE WITH THEIR EPIQ CVX ULTRASOUND SYSTEM DURING HEART SURGERY. THE SURGERY WAS ABORTED, AND THERE WAS NO PATIENT OR USER HARMED AS A RESULT OF 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 23321070 ↗
• MalfunctionOct 16, 2025Unexpected Shutdown; Unexpected Shutdown

  A CUSTOMER WAS REPORTED THAT THE EPIQ CVX ULTRASOUND SYSTEM SHUT DOWN DURING AN UNSPECIFIED CARDIOLOGY OPERATION. ADDITIONAL INFORMATION TO DETERMINE THE TYPE OF PROCEDURE AND PATIENT OUTCOME IS BEING GATHERED. 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 23308720 ↗
• InjuryOct 15, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT AN UNSPECIFIED PROCEDURE IN THE CARDIOVASCULAR OPERATING ROOM WAS UNABLE TO BE COMPLETED ON THE EPIQ CVX ULTRASOUND SYSTEM DUE TO AN IMAGE ARTIFACT. THE USER EXCHANGED THE ULTRASOUND SYSTEM TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE PATIENT IMPACT. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 23284969 ↗
• MalfunctionOct 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE S7-3T TRANSDUCER FAILED ELECTRICAL LEAKAGE TESTING. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. SERVICE HAS BEEN INITIATED TO EVALUATE AND REPLACE THE TRANSDUCER 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 23280986 ↗
• MalfunctionSep 9, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED THEIR EPIQ CVX ULTRASOUND SYSTEM FROZE WITH AN UNSPECIFIED MESSAGE DURING AN UNSPECIFIED SURGERY. THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO USER OR PATIENT HARM AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER COULD NOT DUPLICATE THE REPORTED ISSUE. THE LOGS WERE REVIEWED AND IT WAS DETERMINED THERE WAS POOR CONTACT ON THE CONNECTOR AT THE PROBE CONTACT POINT. THE ENGINEER CLEANED THE CONNECTORS 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 23006130 ↗
• MalfunctionAug 18, 2025Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS SERVICE ENGINEER ARRIVED ON SITE AND COULD NOT VERIFY THE ISSUE. THE PHILIPS SERVICE ENGINEER REPLACED THE BEARING AND SOLENOID, AND THE ISSUE WAS RESOLVED. A THOROUGH ENGINEERING INVESTIGATION HAS BEEN PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS A HARDWARE ISSUE IN THE ARTICULATING ARM LATCHING MECHANISM PREVENTING THE LOCKING SOLENOID FROM FULLY ENGAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827213 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233545, K233788, K240850, K240980, K251651. One submission often covers many models, so check the product and lot details in each record.

• Z-2409-2025 · Jul 3, 2025 · Open, Classified
  X5-1c Transducer Probe
• Z-2406-2025 · Jul 3, 2025 · Open, Classified
  X11-4t Transducer Probe