EPIQ DIAGNOSTIC ULTRASOUND SYSTEM 795231 (UDI 00884838097933)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00884838097933), received between Jun 2, 2021 and Sep 24, 2026 — classified as 3 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (21 reports).

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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888696 ↗
• InjuryMay 3, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A CRITICAL TRANSOESOPHAGEAL ECHOCARDIOGRAM (TOE) PROCEDURE, THE S7-3T TRANSDUCER TRIGGERED AN ON-SCREEN OVER-TEMPERATURE ERROR BANNER WHEN CONNECTED TO THE EPIQ CVX ULTRASOUND SYSTEM. AFTER THE CUSTOMER SWITCHED TO A SECOND SYSTEM, THE SAME ERROR REAPPEARED. THE PHYSICIAN WAS ABLE TO COMPLETE THE CATHETER PLACEMENT USING A TRANSTHORACIC APPROACH. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE PATIENT OUTCOME. THE TRANSDUCER HAS SINCE BEEN REMOVED FROM SERVICE, AND A PHILIPS SERVICE ENGINEER HAS INITIATED A REPLACEMENT TO ADDRESS THE CUSTOMER'S IMMEDIATE NEEDS. PHILIPS HAS OPENED AN INVESTIGATION, AND A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE ASSESSMENT IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 25062481 ↗
• MalfunctionApr 28, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM'S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. 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 25013342 ↗
• MalfunctionMar 30, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM'S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. A PHILIPS SERVICE ENGINEER REPAIRED THE SYSTEM BY REPLACING THE BEARING, WHICH ENSURED THE LOCKING MECHANISM FULLY ENGAGED. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING 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 24714406 ↗
• MalfunctionMar 23, 2026Unexpected Shutdown

  IT WAS REPORTED THE EPIQ CVX ULTRASOUND SYSTEM WAS UNRESPONSIVE AND SHUT DOWN DURING USE IN THE OPERATING THEATER FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SYSTEM. THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER EVALUATED THE SYSTEM INCLUDING THE SYSTEM LOGS TO CONFIRM THE REPORTED PROBLEM. IT WAS DETERMINED WHEN AN X8-2T TRANSDUCER WAS CONNECTED, IT CAUSED THE SYSTEM TO FREEZE AND POWER OFF. THE CUSTOMER WAS NOTIFIED OF THE FINDINGS, AND THE SYSTEM WAS RETURNED TO SERVICE. THERE WERE NO FURTHER SIMILAR ISSUES REPORTED. 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 24663490 ↗
• MalfunctionFeb 11, 2026Material Integrity Problem

  A CUSTOMER REPORTED THEIR S7-3T TRANSDUCER WAS LEAKING FLUID. THIS PROBE IS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF PATIENT USE, AND THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER EVALUATED THE TRANSDUCER TO CONFIRM THE REPORTED PROBLEM AND PROVIDED A REPLACEMENT 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 24316321 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT THE TIP OF THE TRANSESOPHAGEAL X8-2T TRANSDUCER WAS SEPARATING. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER INITIATED THE TRANSDUCER REPLACEMENT PROCESS TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERN. 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 24075433 ↗
• MalfunctionNov 20, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THE X8-2T TRANSDUCER HAD A WIRE COMING OUT FROM THE SHEATH. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM. THE TRANSDUCER WAS REPLACED FROM THE POOL STOCK AT THE CUSTOMER SITE. 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 23609252 ↗
• MalfunctionOct 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THE X8-2T TRANSDUCER FAILED THE ELECTRICAL SAFETY TEST. THE TRANSDUCER WAS ASSICIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 23348537 ↗
• MalfunctionAug 12, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER THAT THE X7-8T TEE TRANSDUCER WOULD NOT ARTICULATE DURING USE WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER REPLACED THE TRANSDUCER TO RESOLVE THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786197 ↗
• MalfunctionJul 24, 2025Electrical /Electronic Property Problem; Material Integrity Problem; Electrical /Electronic Property Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TRANSESOPHAGEAL X8-2T TRANSDUCER HAD A BEND IN THE SHAFT AND FAILED LEAKAGE TESTING. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A REPLACEMENT X8-2T TRANSDUCER WAS SENT TO THE CUSTOMER TO RESOLVE THEIR 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 22601653 ↗
• MalfunctionJun 26, 2025Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A REPLACEMENT BEARING WAS SENT TO THE CUSTOMER TO RESOLVE THE IMMEDIATE ISSUE. A THOROUGH ENGINEERING INVESTIGATION HAS BEEN PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS 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 22336621 ↗
• MalfunctionJun 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE TRANSESOPHAGEAL X8-2T TRANSDUCER FAILED LEAKAGE TESTING. THE LEAKAGE TEST WAS PERFORMED AFTER THE TRANSDUCER DID NOT DISPLAY IMAGES DURING AN EXAMINATION WITH THE EPIQ CVX ULTRASOUND SYSTEM. THE EXAMINATION WAS ABLE TO BE COMPLETED WITH ANOTHER TRANSESOPHAGEAL TRANSDUCER. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A REPLACEMENT X8-2T TRANSDUCER WAS SENT TO THE CUSTOMER TO RESOLVE THEIR 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 22286554 ↗
• MalfunctionJun 17, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE FACILITY¿S BIOMEDICAL ENGINEER SECURED THE BUSHING IN PLACE TO ADDRESS THE IMMEDIATE CONCERN. 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 22224850 ↗
• MalfunctionFeb 25, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS SERVICE ENGINEER RESEATED AND SECURED THE BEARING TO REPAIR THE SYSTEM. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS CAUSED BY A HARDWARE ISSUE IN THE ARTICULATING ARM LATCHING MECHANISM PREVENTING THE LOCKING SOLENOID FROM FULLY ENGAGING. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806 ON 7/16/21. REFERENCE CORRECTIONS AND REMOVAL REPORT NUMBER 3019216-07/16/21-002-C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458154 ↗
• MalfunctionFeb 21, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM'S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE 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 21437841 ↗
• MalfunctionJan 29, 2025Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ CVX ULTRASOUND SYSTEM'S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS SERVICE ENGINEER EVALUATED THE SYSTEM AND VERIFIED THE REPORTED ISSUE. THE BUSHING WAS RESEATED TO REPAIR THE SYSTEM. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS CAUSED BY A HARDWARE ISSUE IN THE ARTICULATING ARM'S LATCHING MECHANISM, WHICH PREVENTED THE LOCKING SOLENOID FROM FULLY ENGAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265003 ↗
• MalfunctionDec 11, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER THAT THE X8-2T TEE TRANSDUCER WOULD NOT ARTICULATE DURING USE WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER REPLACED THE TRANSDUCER TO RESOLVE THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906981 ↗
• MalfunctionNov 7, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM'S CONTROL PANEL DID NOT LOCK PROPERLY WHEN THE MOTION BUTTON WAS DEACTIVATED. THE ISSUE WAS FOUND WHILE TRANSPORTING THE SYSTEM WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER EVALUATED THE SYSTEM AND CONFIRMED THE FAILURE FINDING THE BEARING FLANGE WAS RAISED UP AND NOT ALLOWING THE SOLENOID PISTON TO FULLY ENGAGE. THE BEARING FLANGE WAS REPLACED TO REPAIR THE SYSTEM. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS CAUSED BY A HARDWARE ISSUE IN THE ARTICULATING ARM LATCHING MECHANISM PREVENTING THE LOCKING SOLENOID FROM FULLY ENGAGING. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806 ON 7/16/21. REFERENCE CORRECTIONS AND REMOVAL REPORT NUMBER 3019216-07/16/21-002-C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631594 ↗
• MalfunctionAug 27, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE FIELD SERVICE ENGINEER REPLACED THE SOLENOID TO RESOLVE THE IMMEDIATE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077361 ↗
• MalfunctionAug 26, 2024Material Separation; Material Separation

  PHILIPS RECEIVED REPORT (B)(4) FROM THE FDA'S MEDSUN PROGRAM, WHICH REPORTED DAMAGE TO A TEE TRANSDUCER THAT WAS IDENTIFIED FOLLOWING A TRANSESOPHAGEAL ECHOCARDIOGRAM. AFTER REMOVING THE X8-2T TRANSDUCER FROM THE PATIENT, AN INCH AND A HALF AREA OF MISSING SHEATH WAS FOUND. THE PATIENT HAD A CT SCAN, AND THE RESULTS DID NOT SHOW ANY DISCERNABLE RADIOPAQUE FOREIGN OBJECT OR EVIDENCE OF BOWEL OBSTRUCTION. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW-UP REPORT UPON ITS COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071684 ↗
• MalfunctionJun 27, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THAT AN EPIQ CVX ULTRASOUND SYSTEM'S CONTROL PANEL ARM WAS NOT LOCKING AT THE BASE. THE ISSUE WAS DISCOVERED WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS FIELD SERVICE ENGINEER RESEATED THE CONTROL PANEL BUSHING AND SECURED THE BUSHING IN PLACE, RESOLVING THE REPORTED ISSUE. A THOROUGH ENGINEERING INVESTIGATION HAS BEEN PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS 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 19624364 ↗
• MalfunctionJun 27, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THAT AN EPIQ CVX ULTRASOUND SYSTEM'S CONTROL PANEL WILL NOT LOCK INTO PLACE. THIS ISSUE WAS DISCOVERED WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS FIELD SERVICE ENGINEER RESEATED THE GROMMET (BUSHING) AND SECURED IT INTO PLACE, RESOLVING THE REPORTED ISSUE. A THOROUGH ENGINEERING INVESTIGATION HAS BEEN PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS 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 19624338 ↗
• MalfunctionMay 1, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS SERVICE ENGINEER SECURED THE BEARING WITH LOCTITE TO RESOLVE THE ISSUE. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS 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 19221302 ↗
• MalfunctionFeb 2, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ ELITE ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER REPAIRED THE SYSTEM BY RESEATING AND SECURING THE BUSHING. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THE FAILURE WAS CAUSED BY A HARDWARE ISSUE IN THE ARTICULATING ARM'S LATCHING MECHANISM, WHICH PREVENTED THE LOCKING SOLENOID FROM FULLY ENGAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636230 ↗