EPIQ Diagnostic Ultrasound SystemRecalls & reported problems across all models

We found 9 models of EPIQ Diagnostic Ultrasound System by Philips Ultrasound LLC in the FDA's device registry (GUDID). Together they are named in 281 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2019 and Sep 29, 2026 — classified as 2 deaths, 9 injuries, 270 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (96 reports).

5 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EPIQ Diagnostic Ultrasound System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 9, 2023Class IICompleted

   Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.

   Z-0283-2024 · Root cause: Software design · Recall details · FDA record ↗

2. Jul 14, 2022Class IICompleted

   Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

   Z-1007-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

3. Aug 6, 2021Class IICompleted

   Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

   Z-2484-2021 · Root cause: Software design · Recall details · FDA record ↗

4. Aug 6, 2021Class IICompleted

   Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

   Z-2483-2021 · Root cause: Software design · Recall details · FDA record ↗

5. Dec 24, 2020Class IITerminated

   Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.

   Z-0947-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported EPIQ Diagnostic Ultrasound System problems

EPIQ Diagnostic Ultrasound System models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EPIQ Diagnostic Ultrasound System 989605488741

  Transducer, ultrasonic, diagnostic
  3 recalls165 reports
• EPIQ DIAGNOSTIC ULTRASOUND SYSTEM 795231

  Transducer, ultrasonic, diagnostic
  1 recall47 reports
• EPIQ Diagnostic Ultrasound System 795231

  System, Imaging, Pulsed Doppler, Ultrasonic
  1 recall3 reports
• EPIQ Diagnostic Ultrasound System 795231

  System, Imaging, Pulsed Doppler, Ultrasonic
  37 reports
• EPIQ DIAGNOSTIC ULTRASOUND SYSTEM 795232

  System, imaging, pulsed echo, ultrasonic
  18 reports
• EPIQ Diagnostic Ultrasound System 795232

  System, Imaging, Pulsed Doppler, Ultrasonic
  2 deaths6 reports
• EPIQ Diagnostic Ultrasound System 795232

  System, Imaging, Pulsed Doppler, Ultrasonic
  2 reports
• EPIQ Diagnostic Ultrasound System 795231

  System, Imaging, Pulsed Doppler, Ultrasonic
  2 reports
• EPIQ Diagnostic Ultrasound System 795232

  System, Imaging, Pulsed Doppler, Ultrasonic
  1 report

Recent EPIQ Diagnostic Ultrasound System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Application Program Freezes or Fails to Launch

  It was reported that the EPIQ CVxi Ultrasound System froze with an error message during a TTEER (Transcatheter Tricuspid Edge-to-Edge Repair). The system required multiple reboots to clear the freezing, and an exchange of the ICE Catheter was made without resolving the problem. The procedure was completed by using a TEE transducer instead of an ICE Catheter. There was no 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 50938400 ↗
• MalfunctionSep 24, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888696 ↗
• MalfunctionAug 7, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177876 ↗
• 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 19, 2026Unintended System Motion

  IT WAS REPORTED THAT THE EPIQ CVX ULTRASOUND SYSTEM CONTROL PANEL LOWERED FASTER THAN EXPECTED WHEN THE BRAKE WAS RELEASED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER REPLACED THE CONTROL PANEL GAS STRUTS 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 25223599 ↗
• 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 ↗
• MalfunctionMay 13, 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. A PHILIPS SERVICE ENGINEER REPAIRED THE SYSTEM BY RESEATING AND SECURING THE BEARING, WHICH ALLOWED THE LOCKING MECHANISM TO BE FULLY ENGAGED. 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 ARTICULATING ARM LATCHING MECHANISM PREVENTING THE LOCKING SOLENOID FROM FULLY ENGAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160799 ↗
• MalfunctionMay 8, 2026Unintended 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 FIELD SERVICE ENGINEER REPLACED A BUSHING ON THE BACK OF THE CONTROL PANEL ASSEMBLY TO RESOLVE THE ISSUE. A THOROUGH ENGINEERING INVESTIGATION WAS 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. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131094 ↗
• MalfunctionMay 4, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE EPIQ CVX ULTRASOUND SYSTEM, IN USE WITH AN X8-2T TRANSDUCER, DISPLAYED ERROR MESSAGES DURING A VALUE REPLACEMENT SURGERY. THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER EVALUATED THE SYSTEM BASED ON THE REPORTED PROBLEM AND DETERMINED THE EVENT WAS RELATED TO THE X8-2T TRANSDUCER. THE 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 25071627 ↗
• InjuryMay 3, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A CRITICAL TRANSOESOPHAGEAL ECHOCARDIOGRAM (TOE) PROCEDURE, THE S7-3T TRANSDUCER TRIGGERED AN ON-SCREEN OVER-TEMPERATURE ERROR BANNER WHEN CONNECTED TO THE EPIQ CVX ULTRASOUND SYSTEM. AFTER THE CUSTOMER SWITCHED TO A SECOND SYSTEM, THE SAME ERROR REAPPEARED. THE PHYSICIAN WAS ABLE TO COMPLETE THE CATHETER PLACEMENT USING A TRANSTHORACIC APPROACH. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE PATIENT OUTCOME. THE TRANSDUCER HAS SINCE BEEN REMOVED FROM SERVICE, AND A PHILIPS SERVICE ENGINEER HAS INITIATED A REPLACEMENT TO ADDRESS THE CUSTOMER'S IMMEDIATE NEEDS. PHILIPS HAS OPENED AN INVESTIGATION, AND A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE ASSESSMENT IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 25062481 ↗
• MalfunctionApr 30, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THE X8-2T TRANSDUCER WAS NOT WORKING DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER ONE OR MORE REPORTED RESTARTS OF THE SYSTEM. THERE WAS NO PATIENT OR USER 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 25046894 ↗
• MalfunctionApr 28, 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. 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 25013342 ↗

Other Philips Ultrasound LLC products

• Transducer C5-13 models · 0 reports · 12 recalls
• Transducer X5-13 models · 0 reports · 10 recalls
• EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM5 models · 330 reports · 3 recalls
• Transducer C10-3v2 models · 0 reports · 7 recalls
• Transducer X7-2t4 models · 26 reports · 6 recalls
• Transducer C5-210 models · 0 reports · 6 recalls
• Transducer S5-12 models · 0 reports · 6 recalls
• Transducer L12-55 models · 0 reports · 6 recalls