EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM 795206Recalls & reported problems
Philips Ultrasound LLC · Class 2
All models of EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838097919), received between Oct 18, 2022 and Mar 2, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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
Most reported problems
Device problems
- Material Integrity Problem1
- Patient Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionOct 18, 2022Patient Data Problem; Patient Data Problem
A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A PATIENT¿S DATA WAS MIXED WITH ANOTHER EXAM WHILE USING THEIR EPIQ ULTRASOUND SYSTEM. ACCORDING TO THE CUSTOMER, IMAGES FROM A PREVIOUS STUDY MERGED WITH THE NEXT PATIENT¿S INFORMATION. THE DATA MIX-UP WAS IDENTIFIED BY THE USER AND THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625693 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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