EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEMRecalls & reported problems across all models
Philips Ultrasound LLC · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 5 models of EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM by Philips Ultrasound LLC in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Apr 12, 2019 and Sep 30, 2026 — classified as 1 injury, 76 malfunctions.
The most frequently reported specific device problem is “Unintended System Motion” (27 reports).
2 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
Reports received per month, all models
EPIQ 5 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.
- 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 ↗
- 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 EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM problems
Device problems
- Unintended System Motion27
- Material Integrity Problem17
- Fracture7
- Poor Quality Image5
- Patient Data Problem4
- Break3
- Application Program Freezes or Fails to Launch2
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Congenital Defect/Deformity2
- Hyperextension1
- Insufficient Information1
EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EPIQ 5 Diagnostic Ultrasound System 989605408541System, imaging, pulsed echo, ultrasonic2 recalls68 reports
- EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM 795205Transducer, ultrasonic, diagnostic4 reports
- EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM 795204System, imaging, pulsed doppler, ultrasonic2 reports
- EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM 795206System, imaging, pulsed echo, ultrasonic2 reports
- EPIQ 5 Diagnostic Ultrasound System 795120System, imaging, pulsed doppler, ultrasonic1 report
Recent EPIQ 5 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.
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 ↗MalfunctionMar 2, 2026Material Integrity Problem
A CUSTOMER REPORTED THEIR 3D9-3V TRANSDUCER WAS LEAKING FLUID. THIS PROBE IS ASSOCIATED WITH THE EPIQ 5W 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 24479802 ↗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 ↗
Other Philips Ultrasound LLC products
- Transducer C5-13 models · 0 reports · 12 recalls
- EPIQ Diagnostic Ultrasound System9 models · 281 reports · 5 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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