EPIQ Elite Diagnostic Ultrasound System 795234 (UDI 00884838107540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00884838107540), received between Aug 5, 2023 and Sep 24, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 reports).

3 FDA recall records 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 ↗

2. 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 ↗

3. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Separation

  During service and testing at the manufacturing site, it was found the 3D9-3v transducer casing was gapping/separating. The transducer was associated with an EPIQ Elite Ultrasound System at the customer site. The customer had initially reported to Philips the transducer had image drop out affecting the image quality. A replacement transducer was shipped directly to the customer to address their concerns. The reported issue of casing being gapped/separating was found at the manufacturer site and there was no patient or user harm 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 50886261 ↗
• MalfunctionMay 4, 2026Electrical Overstress

  IT WAS REPORTED THE EPIQ ELITE ULTRASOUND SYSTEM¿S POWER CABLE PIN WAS BURNT. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. THE CUSTOMER SHUT OFF THE SYSTEM. THE SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM AND REPLACED THE POWER MODULE AND THE POWER CABLE 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 25068595 ↗
• MalfunctionApr 30, 2026Fracture

  IT WAS REPORTED THAT THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM. 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 25046890 ↗
• MalfunctionApr 17, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE 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 CLEANING 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 24911867 ↗
• MalfunctionApr 7, 2026Poor Quality Image

  IT WAS REPORTED THAT A CRITICAL PROCEDURE COULD NOT BE COMPLETED ON THE EPIQ ELITE ULTRASOUND SYSTEM DUE TO IMAGE ARTIFACT. THE LIVER BIOPSY PROCEDURE WAS ABLE TO BE COMPLETED ON ANOTHER ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER REPLACED THE ACQUISITION MODULE 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 24802537 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT THE INTRACAVITY 3D9-3V TRANSDUCER PLASTIC HOUSING WAS DAMAGED, EXPOSING METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ ELITE 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 HAS INITIATED THE TRANSDUCER REPLACEMENT 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 24676641 ↗
• MalfunctionMar 3, 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. THIS WAS FOUND OUTSIDE OF PATIENT USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 24497626 ↗
• MalfunctionFeb 6, 2026Material Puncture/Hole

  A CUSTOMER REPORTED THEIR C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ ELITE 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 24283760 ↗
• MalfunctionFeb 3, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE INTRACAVITY 3D9-3V TRANSDUCER WAS LEAKING BLACK FLUID ONTO THE CLOTH WHEN WIPING. THE TRANSDUCER 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 FIELD SERVICE ENGINEER 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 24251868 ↗
• MalfunctionFeb 3, 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 RESEATING 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 24245971 ↗
• MalfunctionJan 30, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE INTRACAVITY 3D9-3V TRANSDUCER WAS LEAKING FLUID AND PEELING. THE TRANSDUCER 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 QUOTE FOR 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 24225842 ↗
• MalfunctionDec 24, 2025Fracture; Fracture

  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 CLINICAL USE AND NO PATIENT OR USER WAS HARMED. INFORMATION WAS PROVIDED RECOMMENDING 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 23888061 ↗
• MalfunctionDec 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRACAVITY 3D9-3V TRANSDUCER WAS LEAKING OIL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ ELITE ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE, DURING PREPARATION. 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 23885939 ↗
• MalfunctionDec 23, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT A CRITICAL PROCEDURE COULD NOT BE COMPLETED ON THE EPIQ ELITE ULTRASOUND SYSTEM. DURING AN EVAR (ENDOVASCULAR ANEURYSM REPAIR), THE SYSTEM SHUT DOWN WHILE BOOTING. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER AN EXCHANGE OF THE ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. A QUALIFIED PHILIPS SERVICE ENGINEER EVALUATED THE SYSTEM BASED ON THE CUSTOMER¿S COMPLAINT AND COULD NOT REPRODUCE THE ISSUE. LOG REVIEW INDICATED HARDWARE MISMATCH, SO THE ENGINEER CONFIRMED SUCCESSFUL HARDWARE TESTING AND RESEATED THE VIDEO CABLES 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 23885872 ↗
• MalfunctionDec 4, 2025Material Integrity Problem; Material Integrity Problem

  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 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 23719694 ↗
• MalfunctionNov 26, 2025Unintended System Motion; Unintended 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, REPLACED 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 23660168 ↗
• MalfunctionNov 25, 2025Break; Break

  A CUSTOMER REPORTED THEIR INTRACAVITY C10-3V PROBE HAD LENS WEAR, EXPOSING METAL COMPONENTS. 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. 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 23646416 ↗
• MalfunctionNov 19, 2025Material Integrity Problem; Material Integrity Problem

  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 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 23594099 ↗
• MalfunctionNov 14, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS. THIS WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE AND 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 23554923 ↗
• MalfunctionNov 5, 2025Material Integrity Problem; Material Integrity Problem

  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 23483096 ↗
• MalfunctionOct 30, 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 FOUND DURING A ROUTINE ULTRASOUND EXAM, AND THERE WAS NO PATIENT OR USER HARM. THE TRANSDUCER WAS REMOVED FROM USE DUE TO THE LENS DAMAGE. A REPLACEMENT TRANSDUCER WAS PROVIDED TO THE CUSTOMER. 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 23426617 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS. THIS WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER¿S IMMEDIATE CONCERNS WERE ADDRESS BY REPLACING 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 23425450 ↗
• MalfunctionOct 27, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THE L12-3 TRANSDUCER DELIVERED A LIGHT ZAP TO A PATIENT. 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: Shock

  MAUDE report 23392889 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD LENS DAMAGE WITH EXPOSED ELECTRONICS. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. INFORMATION WAS PROVIDED TO THE CUSTOMER 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 23392884 ↗
• MalfunctionOct 22, 2025Break; Break

  A CUSTOMER REPORTED THEIR INTRACAVITY C10-3V PROBE HAD LENS DAMAGE, EXPOSING METAL COMPONENTS. 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. 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 23355727 ↗