EPIQ Diagnostic Ultrasound System 795231 (UDI 00884838114135)Recalls & reported problems
Philips Ultrasound LLC · EPIQ CVx Diagnostic Ultrasound System Software version 10.0.X · Class 2
All models of EPIQ Diagnostic Ultrasound System (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838114135), received between May 20, 2025 and May 4, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).
1 FDA recall record 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.
Reports received per month
Recalls naming this device
- 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 ↗
Most reported problems
Device problems
- Application Program Freezes or Fails to Launch1
- Mechanical Jam1
- Unintended System Motion1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Application Program Freezes or Fails to Launch
IT WAS REPORTED THE EPIQ CVX ULTRASOUND SYSTEM, IN USE WITH AN X8-2T TRANSDUCER, DISPLAYED ERROR MESSAGES DURING A VALUE REPLACEMENT SURGERY. THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER EVALUATED THE SYSTEM BASED ON THE REPORTED PROBLEM AND DETERMINED THE EVENT WAS RELATED TO THE X8-2T TRANSDUCER. 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 25071627 ↗MalfunctionFeb 13, 2026Unintended System Motion
IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THERE WAS NO PATIENT OR USER HARM AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER VERIFIED THE REPORTED ISSUE. INFORMATION TO REPLACE THE SOLENOID WAS PROVIDED TO THE CUSTOMER TO ADDRESSED 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 24338812 ↗MalfunctionMay 20, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THE X8-2T TRANSDUCER WOULD NOT ARTICULATE DURING USE. THE TRANSDUCER WAS BEING USED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THE TRANSDUCER WAS EXCHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER INSPECTED AND TESTED THE TRANSDUCER AND NOT ABLE TO VERIFY THE REPORTED ISSUE. THE TRANSDUCER WAS REPLACED 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 22055481 ↗
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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 · each recall links to the FDA recall notice
- 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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