EPIQ CVxi Ultrasound System 795232Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884838107533), received between Sep 24, 2024 and Mar 31, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (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.

Recalls naming this device

1. Jul 14, 2022Class IICompleted

   Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

   Z-1007-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Unexpected Shutdown

  IT WAS REPORTED THE EPIQ CVXI ULTRASOUND SYSTEM WAS NOT AVAILABLE FOR A CATH LAB GUIDED THERAPY PROCEDURE. THE SYSTEM SHUT DOWN DURING THE PROCEDURE. THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER EVALUATED THE SYSTEM AND WAS ABLE TO CONFIRM THE CUSTOMER'S REPORTED PROBLEM. THE ENGINEER REPLACED THE ACQUISITION MODULE 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 24744672 ↗
• MalfunctionDec 3, 2025Failure to Calibrate; Failure to Calibrate

  A CUSTOMER REPORTED DURING A TRICUSPID PROCEDURE THEIR EPIQ CVXI ULTRASOUND SYSTEM DISPLAYED AN ERROR MESSAGE INDICATING THE X8-2T TRANSDUCER COULD NOT BE SELECTED. THE PATIENT WAS MOVED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM AS A RESULT OF THE ISSUE. THE PROBE WAS REPLACED 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 23703388 ↗
• MalfunctionNov 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A CUSTOMER REPORTED THEIR X8-2T TRANSDUCER HAD SEPARATION ON THE SHEATH. THIS PROBE IS ASSOCIATED WITH THE EPIQ CVXI ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF PATIENT USE, AND THERE WAS NO PATIENT OR USER HARM. THE REMOTE ENGINEER EVALUATED THE TRANSDUCER TO CONFIRM THE REPORTED PROBLEM, AND INFORMATION HAS BEEN PROVIDED TO REPLACE THE TRANSDUCER 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 23496500 ↗
• MalfunctionMay 5, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THE EPIQ CVXI ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL TAVI (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE. THE SYSTEM CRASHED DURING THE PROCEDURE AND WAS UNABLE TO BE RECOVERED. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER CONFIRMED, WHEN THE SYSTEM WAS POWERED ON, IT BOOTED TO AN ERROR CODE. 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 21961979 ↗
• MalfunctionMar 29, 2025Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A CRITICAL PROCEDURE WAS INTERRUPTED BY MULTIPLE REBOOTS OF THE EPIQ CVXI ULTRASOUND SYSTEM. DURING A MITRAL VALVE TEER (TRANSCATHETER EDGE-TO-EDGE REPAIR), THE SYSTEM DISPLAYED MISALIGNED IMAGES. TO COMPLETE THE PROCEDURE, THE SYSTEM WAS REBOOTED THREE TIMES. THERE WAS NO REPORTED PATIENT OR USER HARM AS A RESULT OF THIS 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 21727329 ↗
• MalfunctionOct 11, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. THE EPIQ CVXI SYSTEM WAS BEING USED WITH A VERISIGHT ICE CATHETER AND AN X5-1C TRANSDUCER FOR A WATCHMAN CARDIAC PROCEDURE. WHEN SWITCHING BACK FROM USING THE X5-1C TRANSDUCER TO THE ICE CATHETER, THE IMAGE BECAME BLURRY AND UNUSABLE. THE USER ATTEMPTED TO IMPROVE THE IMAGE BY PLUGGING THE CATHETER INTO DIFFERENT PORTS AND ALSO USING DIFFERENT SYSTEM PRESETS. THEN THE DECISION WAS MADE TO RESCHEDULE THE PROCEDURE. THE SYSTEM WAS THEN REBOOTED, WHICH RESOLVED THE IMAGING ISSUE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS 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 20429394 ↗
• MalfunctionSep 24, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THE EPIQ CVXI ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. A PATIENT WAS IN THE CATH LAB WITH A SUSPECTED VSD (VENTRICULAR SEPTAL DEFECT) FOLLOWING AN MI (MYOCARDIAL INFARCTION) AND REQUIRED ULTRASOUND IMAGING TO VERIFY. THE ULTRASOUND SYSTEM WAS DISPLAYING ERROR CODES AND WAS UNABLE TO BOOT UP. THE CARDIAC SONOGRAPHER ATTEMPTED MULTIPLE TIMES TO BOOT THE SYSTEM WITHOUT SUCCESS. ANOTHER VASCULAR ACCESS MACHINE WAS USED TO SCAN THE PATIENT TO VERIFY THE VSD. AT THAT POINTS THE CATHETERIZATION PROCEDURE WAS STOPPED. THE USER AGAIN ATTEMPTED TO BOOT THE ULTRASOUND SYSTEM AFTER REMOVING THE BATTERIES WHICH WAS SUCCESSFUL. THE SYSTEM WAS USED TO CAPTURE IMAGES FOR DOCUMENTATION OF THE MEDICAL CONDITION. THE PATIENT¿S MEDICAL CONDITION WAS DETERMINED TO BE TERMINAL, AND THE PATIENT DIED ON (B)(6) 2024. THE ULTRASOUND SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER EVALUATED THE ULTRASOUND SYSTEM AND WAS NOT ABLE TO BOOT UP THE DEVICE. WHEN ATTEMPTING TO DOWNLOAD THE LOG FILES THEY WERE FOUND TO BE CORRUPTED AND NOT ABLE TO BE OPENED. THE ENGINEER RELOAD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294480 ↗