EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM 795201Recalls & reported problems

Summary

The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 00884838097872), received between Nov 12, 2020 and May 13, 2026 — classified as 175 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (112 reports).

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 25 most recent of 175 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ 7C 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 RESEATED 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 25164320 ↗
• MalfunctionApr 22, 2026Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C 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 FIELD SERVICE ENGINEER RESEATED THE BUSHING ON THE BACK OF THE CONTROL PANEL ASSEMBLY TO RESOLVE THE ISSUE. A THOROUGH ENGINEERING INVESTIGATION WAS 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. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958675 ↗
• MalfunctionApr 17, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ 7C 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 RESEATING 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 24913442 ↗
• MalfunctionFeb 18, 2026Crack

  IT WAS REPORTED THE X8-2T TRANSDUCER HAD A CRACK IN THE SEAM OF THE SHEATH. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ 7C ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER 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 24377597 ↗
• MalfunctionNov 4, 2025Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C 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 THE ARTICULATION ARM BUSHING 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467268 ↗
• MalfunctionOct 29, 2025Electrical /Electronic Property Problem; Material Integrity Problem; Electrical /Electronic Property Problem; Material Integrity Problem

  IT WAS REPORTED THE X8-2T TRANSDUCER HAD A HOLE IN THE SHAFT AND FAILED THE ELECTRICAL SAFETY TEST. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ 7C ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF PATIENT USE AND 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 23413012 ↗
• MalfunctionMay 19, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ 7C 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 OR USER WAS HARMED AS A RESULT OF THIS ISSUE. THE FIELD SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE. THE ENGINEER SCUFFED THE BEARING, THEN RESEATED AND SECURED IT IN PLACE TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS AND ALLOW THE LOCKING MECHANISM TO BE 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 22044046 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THERE WAS DAMAGE TO THE TIP OF A TRANSESOPHAGEAL TRANSDUCER. THE ADHESIVE AT THE TRANSDUCER TIP WAS FALLING OFF AND EXPOSING THE METAL UNDERNEATH. THE X8-2T TRANSDUCER WAS ASSOCIATED WITH THE EPIQ 7C ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED WHILE THE DEVICE WAS OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER EVALUATED THE TRANSDUCER AND CONFIRMED THE DAMAGE. THE TRANSDUCER 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 21667246 ↗
• MalfunctionFeb 5, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED DURING A TRANSESOPHAGEAL ULTRASOUND ELECTROCARDIOGRAM EXAMINATION WITH THE EPIC 7C ULTRASOUND SYSTEM, THE USER PREPARED TO WITHDRAW THE UNSPECIFIED TRANSESOPHAGEAL (TEE) TRANSDUCER; HOWEVER, THE TRANSDUCER WAS UNABLE TO ARTICULATE FORWARD OR BACKWARD. THE TRANSDUCER WAS SUCCESSFULLY REMOVED ONCE A SEDATIVE WAS ADMINISTERED TO THE PATIENT INTRAVENOUSLY. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO REPORTED PATIENT NOR 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 21315322 ↗
• MalfunctionDec 6, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C 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 RE-SEATED THE BUSHING TO RESOLVE THE 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 20863986 ↗
• MalfunctionDec 2, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER THAT THE X7-8T TEE TRANSDUCER WOULD NOT ARTICULATE DURING USE WITH AN EPIQ 7C ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE EXAM WAS COMPLETED WITHOUT DELAY. 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 20826682 ↗
• MalfunctionOct 4, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE EPIQ 7C ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. DURING AN UNSPECIFIED OPEN-HEART SURGERY, THE SYSTEM WAS DISPLAYING POOR QUALITY IMAGES. THE USER EXCHANGED THE TRANSDUCER A FEW TIMES AND THEN EXCHANGED THE SYSTEM. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO PATIENT OR USER HARM. THE BIOMEDICAL ENGINEERING REPORTED THAT THE ISSUE WAS RESOLVED BY RESEATING THE POWER REGULATOR AND THE ACB BOARD. 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 20370203 ↗
• MalfunctionSep 24, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE EPIQ 7C ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. THE SYSTEM FROZE WITH AN ERROR CODE DURING AN UNSPECIFIED OPEN-HEART SURGERY AND WAS UNABLE TO BE USED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PROCEDURE WAS ABLE TO BE COMPLETED. NO FURTHER INFORMATION WAS AVAILABLE. PHILIPS REMOTE ENGINEER REVIEWED THE SYSTEM LOGS AND VERIFIED AN ERROR CODE ASSOCIATED WITH THE VECTOR PHYSIO BOARD. THE ENGINEER ORDERED A REPLACEMENT PHYSIO BOARD AND PHYSIO BOARD EXTENDER TO BE SHIPPED DIRECTLY TO THE CUSTOMER TO REPAIR THE SYSTEM. THE PARTS WERE NOT SAVED FOR FURTHER INVESTIGATION. 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 20293476 ↗
• MalfunctionSep 17, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THAT AN EPIQ 7C CONTROL PANEL ARM WILL NOT LOCK INTO POSITION WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS SERVICE ENGINEER REMOVED THE SOLENOID AND LOCKING COLLAR, CLEANED THE LOCKING COLLAR AND HOLE, APPLIED LOCTITE AND REINSTALLED SOLENOID TO RESOLVE THE 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 20237852 ↗
• MalfunctionAug 23, 2024Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  A USER FACILITY MEDSUN (# (B)(4) ) WAS RECEIVED REPORTING THE FOLLOWING: DURING CARDIAC SURGERY, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) MACHINE WORKED FOR INITIAL EXAM. SUBSEQUENTLY THE ECHO IMAGE FROZE AND ANESTHESIOLOGIST WAS UNABLE TO COMPLETE ECHO. STEPS TAKEN TO RESTART MACHINE UNSUCCESSFUL. NEW TEE MACHINE OBTAINED FROM HEART STATION. IT IS UNKNOWN WHAT SURGERY WAS PERFORMED. NO PATIENT HARM WAS REPORTED. THE REPORTED INDICATED THAT A PRODUCT PROBLEM OCCURRED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED, THE MEDSUN DOCUMENTED A NEW TEE MACHINE WAS OBTAINED FROM THE HEART STATION. ALTHOUGH MULTIPLE ATTEMPTS WERE MADE, NO FURTHER INFORMATION WAS RECEIVED FROM THE CUSTOMER. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20054449 ↗
• MalfunctionAug 6, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7CV 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 19923448 ↗
• MalfunctionJul 16, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  : IT WAS REPORTED THE EPIQ 7C ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. A BFARM 21347-24 REPORT WAS RECEIVED ASSOCIATED WITH THIS EVENT. THE SYSTEM WAS BEING USED WITH AN X5-1 TRANSDUCER FOR AN EMERGENCY EVALUATION OF THE PATIENT¿S AORTIC VALVE. THE PATIENT HAD A PAST AORTIC VALVE REPLACEMENT AND WAS IN ACUTE HEMODYNAMIC INSTABILITY. IN THE BEGINNING OF THE EXAM, THE SYSTEM DISPLAYED AN ERROR MESSAGE THAT THE TRANSDUCER WAS NOT ABLE TO BE DETECTED AND THE SYSTEM SHUT DOWN. THE SYSTEM WAS REBOOTED WITHOUT THE TRANSDUCER CONNECTED, AND WHEN THE TRANSDUCER WAS RECONNECTED, IT HAD THE SAME RESULTS AND THE SYSTEM SHUT DOWN AGAIN. THE EXAM WAS NOT ABLE TO BE COMPLETED. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE PATIENT WAS TREATED FOR HIS MEDICAL CONDITIONS IN THE HOSPITAL AND HAS BEEN TRANSFERRED TO A REHABILITATION CLINIC. THE CUSTOMER HAS SENT THE TRANSDUCER FOR A THIRD-PARTY REPAIR. 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 19754743 ↗
• MalfunctionJul 9, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7CV 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 19706689 ↗
• MalfunctionJul 9, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE S7-3T TRANSDUCER WAS NOT ARTICULATING PROPERLY DURING A ROUTINE TEE EXAM. THE USER EXCHANGED THE PROBE TO COMPLETE THE EXAMINATION. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE ENGINEER HAS NOT YET BEEN TO THE FACILITY TO EVALUATE THE TRANSDUCER. 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 19702018 ↗
• MalfunctionJul 2, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED AN X8-2T TRANSDUCER WOULD NOT CONSISTENTLY RESPOND TO THE ARTICULATION DIAL DURING PATIENT USE. THE TRANSDUCER WAS BEING USED WITH AN EPIQ 7C ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER EVALUATED THE TRANSDUCER AND CONFIRMED THE ANGLE BUTTONS WERE NOT FUNCTIONING AS EXPECTED THE IMAGE VIEW STOPPED AND WENT IN REVERSE ONCE. A RECOMMENDATION TO REPLACE THE TRANSDUCER WAS PROVIDED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657695 ↗
• MalfunctionJun 17, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C 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 EVALUATED THE SYSTEM TO FIND THE GAS STRUT WAS OUT OF ADJUSTMENT WHICH CAUSED THE SYSTEM TO SWIVEL AND NOT BE LOCKED PROPERLY. THE STRUT WAS REPLACED TO REPAIR THE SYSTEM. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549091 ↗
• MalfunctionMay 10, 2024Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C 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 REPLACED THE BEARING AND SOLENOID 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 19286594 ↗
• MalfunctionApr 25, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE EPIQ 7C ULTRASOUND SYSTEM GENERATED AN ERROR CODE DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE USER REPLACED THE SYSTEM AND CAUSED NO IMPACT TO THE PATIENT. THE SERVICE ENGINEER EVALUATED THE SYSTEM AND DETERMINED THERE WAS NO HARDWARE FAILURES ON THE SYSTEM TEST WHICH INDICATED A SOFTWARE ISSUE. THE ENGINEER RELOADED AND UPDATED THE SOFTWARE TO REPAIR THE ISSUE. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183041 ↗
• MalfunctionApr 25, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE EPIQ 7C ULTRASOUND SYSTEM LOCKED UP WITH AN ERROR CODE DURING A HEART SURGERY WHILE USING AN UNSPECIFIED TOE PROBE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER EVALUATED THE SYSTEM AND REPLACED THE ACQUISITION MODULE DUE TO AN ERROR. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182355 ↗
• MalfunctionApr 12, 2024Unintended System Motion; Unintended System Motion

  PROPOSED B5 TEXT: A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C 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 REPLACED THE BEARING AND POWER CABLE. VISUAL INSPECTION FOUND THE BEARING/FLANGE HAD RISEN UP OUT OF THE ULTRASOUND SYSTEM CHASSIS. A THOROUGH ENGINEERING INVESTIGATION HAS BEEN 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 19095324 ↗