EPIQ 5 Diagnostic Ultrasound System 989605408541Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00884838047686), received between Apr 12, 2019 and Sep 30, 2026 — classified as 1 injury, 67 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (24 reports).

2 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.

Recalls naming this device

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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Poor Quality Image

  Patient problems: Insufficient Information

  MAUDE report 50952445 ↗
• MalfunctionSep 24, 2026Crack

  During service and testing at the manufacturing site, it was found the 3D9-3v transducer casing was cracked. The transducer was associated with an EPIQ 5W Ultrasound System at the customer site. The customer had initially reported to Philips the transducer had a cracked strain relief. A replacement transducer was shipped directly to the customer to address their concerns. The reported issue of cracked casing 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 50886260 ↗
• MalfunctionMay 8, 2026Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 5G 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 ENGINEER PROVIDED INSTRUCTIONS TO THE BIOMED ON PROPER PROCEDURE TO INSPECT AND SECURE CPA BEARING ON THE BACK OF THE CONTROL PANEL ASSEMBLY TO RESOLVE THE ISSUE. THE BIOMED IS TAKING RESPONSIBILITY FOR THE REPAIR. 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 25131049 ↗
• MalfunctionApr 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE INTRACAVITY MODEL 3D9-3V PROBE WAS LEAKING OIL FROM THE LENS AREA. THE PROBE WAS ASSOCIATED WITH THE EPIQ 5G 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'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 24792899 ↗
• 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 5G ULTRASOUND SYSTEM. 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 24744669 ↗
• MalfunctionMar 3, 2026Fracture

  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 5 ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM. A QUALIFIED SERVICE ENGINEER EVALUATED THE TRANSDUCER TO CONFIRM THE REPORTED PROBLEM, AND THE TRANSDUCER WAS REPLACED 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 24503556 ↗
• MalfunctionMar 3, 2026Unintended System Motion

  IT WAS REPORTED THE CONTROL PANEL ARM ON AN EPIQ 5G ULTRASOUND SYSTEM LOWERS QUICKER THAN NORMAL. 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 24496888 ↗
• MalfunctionMar 2, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ 5G ULTRASOUND SYSTEM'S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE SYSTEM WITHING THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. THE SERVICE ENGINEER CLEANED THE LOCKING MECHANISM 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 24483272 ↗
• MalfunctionFeb 27, 2026Fracture

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THIS WAS ASSOCIATED WITH AN EPIQ 5G ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE TRANSDUCER WAS REPLACED 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 24470918 ↗
• MalfunctionFeb 10, 2026Fracture

  A CUSTOMER REPORTED THAT THE C10-3V PROBE HAD A HOLE IN THE LENS WITH EXPOSED METAL. THE PROBE IS USED WITH THE EPIQ 5 ULTRASOUND SYSTEM. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE AND REPLACED THE PROBE 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 24305223 ↗
• MalfunctionFeb 4, 2026Unintended System Motion

  A CUSTOMER REPORTED THE CONTROL PANEL ARM ON THEIR EPIQ 5G ULTRASOUND SYSTEM DROPPED RAPIDLY. THERE WAS NO PATIENT OR USER HARM. THE ACTUATION AND NON-ACTUATION GAS STRUTS WERE SHIPPED 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 24257107 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT THE C10-3V TRANSDUCER HAD A HOLD IN THE LENS, RESULTING IN EXPOSED METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ 5 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 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 24203738 ↗
• MalfunctionJan 15, 2026Fracture

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ 5G ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 24081072 ↗
• MalfunctionJan 6, 2026Material Integrity Problem

  A CUSTOMER REPORTED THEIR C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ 5G 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 23973812 ↗
• MalfunctionDec 24, 2025Fracture; Fracture

  IT WAS REPORTED THE C9-4V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THIS WAS ASSOCIATED WITH AN EPIQ 5G ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. INFORMATION WAS PROVIDED TO THE CUSTOMER FOR A REPLACEMENT PART 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 23888286 ↗
• MalfunctionDec 22, 2025Break; Break

  A CUSTOMER REPORTED THEIR INTRACAVITY C10-3V TRANSDUCER HAD LENS DAMAGE, EXPOSING METAL COMPONENTS. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ 5 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 23863238 ↗
• MalfunctionDec 10, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED THEIR EPIQ 5 ULTRASOUND SYSTEM LOCKED UP MULTIPLE TIMES DURING A BREAST BIOPSY REQUIRING THE TECH TO REBOOT THE SYSTEM EACH TIME. THERE WAS NO REPORTED PATIENT OR USER HARM AS A RESULT OF THE ISSUE. NO ADDITIONAL INFORMATION COULD BE OBTAINED 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 23770652 ↗
• MalfunctionDec 3, 2025Material Integrity Problem; Material Integrity Problem

  A CUSTOMER REPORTED THEIR C10-3V TRANSDUCER¿S SCAN HEAD WAS DAMAGED, RESULTING IN EXPOSED METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ 5 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. A PHILIPS 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 23709267 ↗
• MalfunctionNov 14, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THIS WAS ASSOCIATED WITH AN EPIQ 5G ULTRASOUND SYSTEM. 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 23556150 ↗
• MalfunctionNov 12, 2025Material Integrity Problem; Material Integrity Problem

  A CUSTOMER REPORTED THEIR 3D9-3V TRANSDUCER WAS LEAKING FLUID. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ 5W ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THERE WAS NO PATIENT NOR 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 23535865 ↗
• MalfunctionNov 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD DAMAGE TO THE LENS. THIS WAS ASSOCIATED WITH AN EPIQ 5G 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 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 23467267 ↗
• MalfunctionNov 4, 2025Crack; Crack

  A CUSTOMER REPORTED THAT THE C10-3V TRANSDUCER LENS WAS BROKEN. THIS TRANSDUCER WAS ASSOCIATED WITH AN EPIQ 5 ULTRASOUND SYSTEM. THE FAILURE OCCURRED 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 23466814 ↗
• MalfunctionNov 4, 2025Material Integrity Problem; Material Integrity Problem

  A CUSTOMER REPORTED THEIR 3D9-3V TRANSDUCER WAS LEAKING FLUID. THIS PROBE IS ASSOCIATED WITH THE EPIQ 5 ULTRASOUND SYSTEM. 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 23465270 ↗
• 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 5G ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER¿S IMMEDIATE CONCERNS WERE ADDRESSED BY PROVIDING INFORMATION TO REPLACE 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 23425632 ↗
• MalfunctionOct 29, 2025Material Integrity Problem; Material Integrity Problem

  A CUSTOMER REPORTED THEIR C10-3V INTRACAVITY TRANSDUCER HAD HOLES IN THE LENS EXPOSING ELECTRONICS. THIS PROBE IS ASSOCIATED WITH THE EPIQ 5G 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 23416638 ↗