EPIQ Elite Diagnostic Ultrasound System 795234 (UDI 00884838124912)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838124912), received between Jul 16, 2025 and Mar 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 7, 2026Class IIOpen, Classified

   Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

   Z-3249-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

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.

• MalfunctionMar 23, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ ELITE ULTRASOUND SYSTEM'S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE SYSTEM WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OF USER WAS HARMED. THE SERVICE ENGINEER RESEATED THE ARTICULATION ARM BUSHING TO REPAIR THE SYSTEM. THE ENGINEER TEAM DETERMINED THE FAILURE WAS CAUSED BY A HARDWARE ISSUE IN THE ARTICULATING ARM LATCHING MECHANISM PREVENTING THE LOCKING SOLENOID FROM FULLY ENGAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663488 ↗
• MalfunctionDec 24, 2025Fracture; Fracture

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THIS WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. INFORMATION WAS PROVIDED TO THE CUSTOMER FOR A REPLACEMENT PART TO ADDRESS 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 23888228 ↗
• MalfunctionJul 16, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT THE EPIQ ELITE ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL OB (OBSTETRICS) EXAMINATION. THE SYSTEM DISPLAYED AN ERROR CODE THREE TIMES INDICATING RESTART OR SHUT DOWN WAS NEEDED AFTER ACQUIRING CINEMATIC LOOPS. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER MULTIPLE REBOOTS. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER ADVISED THE CUSTOMER TO WAIT 6-10 SECONDS AFTER ACQUIRING THE CINEMATIC LOOP BEFORE ENTERING REVIEW, AS A WORKAROUND, TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERNS. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE CAUSE OF THE REPORTED ISSUE. IT WAS DETERMINED THAT THE REPORTED PROBLEM WAS SOFTWARE RELATED. ANY ACTIONS NEEDED TO RESOLVE THIS ISSUE WILL BE CONSIDERED FOR DEVELOPMENT AND IMPLEMENTED IN FUTURE SOFTWARE UPDATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516814 ↗