EPIQ Diagnostic Ultrasound System 795232 (UDI 00884838123977)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838123977), received between Jan 7, 2025 and Sep 29, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K233545, K233788, K240850, K240980, K251651); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Application Program Freezes or Fails to Launch

  It was reported that the EPIQ CVxi Ultrasound System froze with an error message during a TTEER (Transcatheter Tricuspid Edge-to-Edge Repair). The system required multiple reboots to clear the freezing, and an exchange of the ICE Catheter was made without resolving the problem. The procedure was completed by using a TEE transducer instead of an ICE Catheter. There was no user or patient 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 50938400 ↗
• MalfunctionJan 7, 2025Unexpected Shutdown; Application Program Freezes or Fails to Launch; Unexpected Shutdown; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED THEIR EPIQ CVXI ULTRASOUND SYSTEM SHUT DOWN THREE TIMES DURING TAVI HEART SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE ACQUISITION MODULE AND POWER REGULATOR WERE REPLACED TO RESOLVE THE 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 21090443 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233545, K233788, K240850, K240980, K251651. One submission often covers many models, so check the product and lot details in each record.

• Z-2406-2025 · Jul 3, 2025 · Open, Classified
  X11-4t Transducer Probe
• Z-2409-2025 · Jul 3, 2025 · Open, Classified
  X5-1c Transducer Probe