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EPIQ Diagnostic Ultrasound System 989605488741Recalls & reported problems

Philips Ultrasound LLC · Class 2

All models of EPIQ Diagnostic Ultrasound System (9)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Philips EPIQ ultrasound system has 167 reports, with no deaths and 1 injury. Many reports describe the control panel arm moving or dropping unexpectedly, the software freezing, and parts coming loose, and most say no one was harmed. The system has three recalls, all closed: two over a software defect that could lock up the system when leaving review mode, and one over control panel screws that could come loose and break off under pressure.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
165
Deaths reported
0
Injuries reported
1
Recalls naming it
3

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 00884838088658), received between Aug 29, 2019 and May 19, 2026 — classified as 1 injury, 164 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (67 reports).

3 FDA recall records name this device's 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, 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.

Reports received per month

Nov 2023: 5 reportsDec 2023: 8 reportsJan 2024: 3 reportsFeb 2024: 1 reportsMar 2024: 5 reportsApr 2024: 2 reportsMay 2024: 2 reportsJun 2024: 5 reportsJul 2024: 4 reportsAug 2024: 3 reportsSep 2024: 4 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 3 reportsJan 2025: 3 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 2 reportsSep 2025: 2 reportsOct 2025: 11 reportsNov 2025: 3 reportsDec 2025: 3 reportsJan 2026: 4 reportsFeb 2026: 0 reportsMar 2026: 3 reportsApr 2026: 4 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202611
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. 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 ↗

  2. 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 ↗

  3. 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 problems

Device problems

  • Unintended System Motion67
  • Application Program Freezes or Fails to Launch18
  • Mechanical Jam14
  • Electrical /Electronic Property Problem12
  • Unintended Application Program Shut Down10
  • No Device Output6
  • Patient Data Problem6
  • Detachment of Device or Device Component5

Patient problems

  • No Clinical Signs, Symptoms or Conditions151
  • No Consequences Or Impact To Patient9
  • No Known Impact Or Consequence To Patient7
  • Laceration(s)2
  • Gastroesophageal Burn1
  • Insufficient Information1
  • No Information1
  • Perforation1

Recent adverse event reports

The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.

  • 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 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 ↗
  • 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 24, 2026Application Program Freezes or Fails to Launch

    IT WAS REPORTED THAT THE EPIQ CVX ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING AN UNSPECIFIED CRITICAL TEE PROCEDURE. THE SYSTEM FROZE DURING USE AND THE USER EXCHANGED THE SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER WAS ABLE TO EVALUATE THE DEVICE LOGS TO CONFIRM THE REPORTED PROBLEM. THE SERVICE ENGINEER REPLACED THE ACQUISITION MODULE TO RESOLVE THE CUSTOMER¿S IMMEDIATE ISSUE. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED. 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 24985202 ↗
  • MalfunctionApr 24, 2026Unintended System Motion

    IT WAS REPORTED THAT THE CONTROL PANEL ARM ON AN EPIQ CVX ULTRASOUND SYSTEM DROPPED RAPIDLY. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE, AND THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER REPLACED THE CONTROL PANEL ARM GAS STRUTS TO RESOLVE THE CUSTOMER¿S 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 24984841 ↗
  • MalfunctionApr 3, 2026Material Integrity Problem

    IT WAS REPORTED THE MONITOR ARM OF THE EPIQ CVX ULTRASOUND SYSTEM BECAME DETACHED. THIS EVENT OCCURRED OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED. THE SERVICE ENGINEER REPLACED THE MONITOR ARM 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 24778144 ↗
  • MalfunctionMar 20, 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24653367 ↗
  • MalfunctionMar 4, 2026Break

    IT WAS REPORTED THE X8-2T TRANSDUCER HAD A BROKEN SEAL AROUND THE LENS. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM. INFORMATION HAS BEEN PROVIDED TO THE CUSTOMER TO REPLACE THE TRANSDUCER TO ADDRESS 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 24506137 ↗
  • MalfunctionMar 4, 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. THE FIELD SERVICE ENGINEER REPLACED THE SOLENOID TO RESOLVE THE CUSTOMER'S IMMEDIATE CONCERNS. 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24504852 ↗
  • MalfunctionJan 28, 2026Application Program Freezes or Fails to Launch

    IT WAS REPORTED THAT THE EPIQ CVX ULTRASOUND SYSTEM WAS UNAVAILABLE DURING AN UNSPECIFIED CRITICAL PROCEDURE; THE SYSTEM DISPLAYED ERROR MESSAGES. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER MULTIPLE REBOOTS OF THE SYSTEM, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER HAD THE CUSTOMER UNPLUG THE SYSTEM¿S POWER AND WAIT BEFORE POWERING ON AGAIN 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 24205566 ↗
  • MalfunctionJan 15, 2026Fracture

    IT WAS REPORTED THE X8-2T TRANSDUCER HAD A BREAK IN THE SEAM OF THE SHEATH CREATING A SHARP EDGE. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER PROVIDED THE CUSTOMER WITH INFORMATION FOR A REPLACEMENT TO ADDRESS 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 24081094 ↗
  • MalfunctionJan 13, 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 PERFORMED A SYSTEM INSPECTION AND, AS A CORRECTION, RESEATED AND REAFFIXED THE REAR ARM BUSHING 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 24057898 ↗
  • MalfunctionJan 2, 2026Material Integrity Problem

    A CUSTOMER REPORTED THEIR X8-2T TRANSDUCER HAD A HOLE IN THE TIP WITH EXPOSED METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. A PHILIPS SERVICE ENGINEER 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 23947684 ↗
  • MalfunctionDec 31, 2025Unintended System Motion; Unintended System Motion

    A CUSTOMER REPORTED THAT THE SWIVEL MECHANISM OF THEIR EPIQ CVXI 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 RE-SEATED THE BUSHING TO RESOLVE THE ISSUE. 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 23933165 ↗
  • MalfunctionDec 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE TRANSESOPHAGEAL X8-2T TRANSDUCER¿S SEALANT ON THE TIP WAS COMING OFF. 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. THE PHILIPS SERVICE ENGINEER REPLACED THE TRANSDUCER 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 23843766 ↗
  • MalfunctionDec 10, 2025Unexpected Shutdown; Application Program Freezes or Fails to Launch; Unexpected Shutdown; Application Program Freezes or Fails to Launch

    A CUSTOMER REPORTED THE EPIQ CVX ULTRASOUND SYSTEM LOCKED UP DURING AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER TEE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER AN EXCHANGE OF THE ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 23769420 ↗
  • MalfunctionNov 20, 2025Crack; Crack

    IT WAS REPORTED THE S7-3T TRANSDUCER HAD A CRACK IN THE SHEATHING NEAR THE HANDLE. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE AND REPLACED 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 23606142 ↗
  • MalfunctionNov 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THE X8-2T TRANSDUCER FAILED THE ELECTRICAL SAFETY TEST. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. A REPLACEMENT TRANSDUCER WAS SHIPPED DIRECTLY TO THE CUSTOMER TO ADDRESS 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 23464545 ↗
  • MalfunctionNov 3, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

    IT WAS REPORTED A CUSTOMER¿S EPIQ CVX ULTRASOUND SYSTEM DISPLAYED A LATENCY ERROR MESSAGE SEVERAL TIMES DURING A CRITICAL PROCEDURE. THE SYSTEM WAS REBOOTED MULTIPLE TIMES TO COMPLETE THE PROCEDURE WITH THE SAME 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 23453583 ↗
  • MalfunctionOct 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THAT THE TRANSESOPHAGEAL X8-2T 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. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT TRANSDUCER TO ADDRESS 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 23432685 ↗
  • MalfunctionOct 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THAT THE X8-2T TRANSDUCER FAILED ELECTRICAL LEAKAGE TESTING. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE OCCURRED OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. A PHILIPS FIELD SERVICE ENGINEER 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 23417292 ↗
  • MalfunctionOct 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    A CUSTOMER REPORTED THEIR X8-2T TRANSDUCER FAILED THE ELECTRICAL LEAKAGE TEST. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIC 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. 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 23405888 ↗
  • MalfunctionOct 28, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

    A CUSTOMER REPORTED THEIR EPIQ CVX ULTRASOUND SYSTEM SHUT DOWN DURING A TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT). 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 23405332 ↗
  • MalfunctionOct 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THE X8-2T TRANSDUCER FAILED THE ELECTRICAL SAFETY TEST. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE AND REPLACED 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 23357286 ↗
  • MalfunctionOct 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    A CUSTOMER REPORTED THE X8-2T PROBE FAILED THE ELECTRICAL LEAKAGE TEST. THE PROBE WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS FOUND OUTSIDE OF PATIENT USE, AND 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 23356622 ↗

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