EPIQ Elite Diagnostic Ultrasound System 795234 (UDI 00884838102514)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00884838102514), received between Jan 2, 2025 and Mar 31, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 7, 2026Class IIOpen, Classified

   Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

   Z-3249-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THIS WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF PATIENT USE. 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 24744670 ↗
• MalfunctionMar 11, 2026Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ ELITE 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 BUSHING 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 24568802 ↗
• MalfunctionMar 10, 2026Unintended System Motion

  IT WAS REPORTED THAT, WHEN RELEASING THE CONTROL PANEL LOCK ON THE EPIQ ELITE ULTRASOUND SYSTEM, THE CONTROL PANEL LOWERED FASTER THAN EXPECTED. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE, DURING PREVENTATIVE MAINTENANCE, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER HAS INITIATED THE REPAIR PROCESS 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 24563001 ↗
• MalfunctionMar 4, 2026Material Split, Cut or Torn

  A CUSTOMER REPORTED THEIR C10-3V INTRACAVITY TRANSDUCER EXHIBITED SOME DAMAGE TO THE LENS TIP AREA EXPOSING A PORTION OF THE METAL LAYER UNDERNEATH. THIS PROBE IS ASSOCIATED WITH THE EPIQ ELITE ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM. THE CUSTOMER'S COMPLAINT WAS ADDRESSED BY PROVIDING INFORMATION FOR A REPLACEMENT 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 24507626 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT THE C10-3V TRANSDUCER LENS HAD A HOLE, RESULTING IN EXPOSED METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ ELITE DIAGNOSTIC 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. 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 24264169 ↗
• MalfunctionJan 29, 2026Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ ELITE 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 24217731 ↗
• MalfunctionJan 13, 2026Material Integrity Problem

  A CUSTOMER REPORTED THEIR 3D9-3V TRANSDUCER WAS LEAKING OIL. THIS PROBE IS ASSOCIATED WITH THE EPIQ ELITE ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF PATIENT 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 24057320 ↗
• MalfunctionNov 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A CUSTOMER REPORTED THEIR C10-3V TRANSDUCER¿S LENS WAS DAMAGED, RESULTING IN EXPOSED METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ ELITE 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 23639401 ↗
• MalfunctionOct 31, 2025Material Integrity Problem; Material Integrity Problem

  A CUSTOMER REPORTED THEIR C10-3V TRANSDUCER HAD DAMAGED ON THE LENS EXPOSING CRYSTALS. THIS PROBE IS ASSOCIATED WITH THE EPIQ ELITE ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF PATIENT USE, AND THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER EVALUATED THE TRANSDUCER TO CONFIRM THE REPORTED PROBLEM 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 23434158 ↗
• MalfunctionOct 27, 2025Electrical /Electronic Property Problem; Material Integrity Problem; Electrical /Electronic Property Problem; Material Integrity Problem

  IT WAS REPORTED THE 3D9-3V TRANSDUCER HAD LENS DAMAGE THAT FAILED THE ELECTRICAL SAFETY TEST. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 23392890 ↗
• MalfunctionSep 15, 2025Material Integrity Problem; Material Integrity Problem

  A CUSTOMER REPORTED THEIR C10-3V TRANSDUCER HAD A HOLE IN THE LENS EXPOSING ELECTRONICS. THIS PROBE IS ASSOCIATED WITH THE EPIQ ELITE ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF PATIENT USE, AND THERE WAS NO PATIENT OR USER HARM. A REPLACEMENT PROBE 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 23057080 ↗
• MalfunctionSep 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A CUSTOMER REPORTED THE C10-3V TRANSDUCER HAD DAMAGE TO THE LENS SURFACE EXPOSING METAL UNDERNEATH. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. INFORMATION WAS PROVIDED REGARDING REPLACEMENT OF THE 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 22994679 ↗
• MalfunctionAug 27, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE INTRACAVITY 3D9-3V PROBE WAS LEAKING OIL FROM TIP. THE PROBE WAS ASSOCIATED WITH THE EPIQ ELITE 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. 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 22903897 ↗
• MalfunctionJan 2, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ ELITE ULTRASOUND SYSTEM¿S CONTROL PANEL ARM WILL NOT LOCK INTO POSITION WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. NO PATIENT OR USER WAS HARMED BECAUSE OF THE ISSUE. A PHILIPS SERVICE ENGINEER REMOVED THE CONTROL PANEL ARM COVERS AND FOUND THE BUSHING AROUND THE LOWER SWIVEL LOCK LATCH WAS OUT OF PLACE. THE PHILIPS SERVICE ENGINEER CLEANED THE GREASE AND RESIDUE FROM THE HOLE WHERE THE BUSHING SEATS AND APPLIED LOCTITE 480 TO THE BUSHING AND SEATED IT FIRMLY IN PLACE 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 21057342 ↗