EPIQ Diagnostic Ultrasound System 795232 (UDI 00884838126930)Recalls & reported problems
Philips Ultrasound LLC · EPIQ CVxi Diagnostic Ultrasound System Software version 13.0 · Class 2
All models of EPIQ Diagnostic Ultrasound System (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838126930), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Poor Quality Image” (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
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT A CRITICAL PROCEDURE WITH THE X8-2T TRANSDUCER COULD NOT BE COMPLETED ON THE EPIQ CVXI ULTRASOUND SYSTEM, DUE TO DEGRADED IMAGE QUALITY. THE TRANSCATHETER TRICUSPID VALVE EDGE-TO-EDGE REPAIR WAS ABLE TO BE COMPLETED AFTER THE SYSTEM WAS EXCHANGED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION IS BEING OBTAINED. 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 23607285 ↗
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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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