EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM 795202Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838097889), received between Dec 5, 2022 and Apr 9, 2025 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2025Material Integrity Problem; Material Integrity Problem

  AS PART OF CAPA 5677695, IT WAS IDENTIFIED THAT RETROSPECTIVE REVIEW ACTIVITIES WERE WARRANTED FOR INTRACAVITY TRANSDUCER DAMAGE IF PHYSICALLY SPLIT, FRACTURED, OR CONTAINS SHARP EDGES ON THE TRANSDUCER, REGARDLESS OF WHETHER THE DEVICE IS IN CLINICAL USE. PHILIPS ULTRASOUND IS REPORTING THIS COMPLAINT AS PART OF THE RETROSPECTIVE REVIEW COMPLETED FOR INTRACAVITY TRANSDUCER DAMAGE. IT WAS REPORTED THE C10-3V TRANSDUCER HAD A LARGE HOLE IN THE LENS AND ABLE TO SEE INSIDE. THIS TRANSDUCER WAS ASSOCIATED WITH AN EPIQ 7W 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 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 21804939 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  A CUSTOMER REPORTED THEIR 3D9-3V TRANSDUCER BROKE IN HALF DURING THE CLEANING PROCESS. THERE WAS NO HARM OR INJURY REPORTED TO THE PATIENT OR USER, THE DEVICE THE WAS NOT IN CLINICAL USE. ANALYSIS WAS PERFORMED BY ONSITE FIELD SERVICE ENGINEER WHO CONFIRMED THE REPORTED ISSUE. THE RESULTS OF THE ANALYSIS CONFIRMED THE TRANSDUCER WAS BROKEN IN HALF NEAR THE BASE. THE ISSUE WAS RESOLVED BY REPLACING THE TRANSDUCER AND THE PRODUCT IS BACK IN SERVICE. PHILIPS HAS STARTED AN INVESTIGATION INTO THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380449 ↗
• MalfunctionDec 5, 2022Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A PATIENT'S DATA WAS MIXED WITH ANOTHER EXAM ON THE EPIQ ULTRASOUND SYSTEM. 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 15915357 ↗