EPIQ 7 Diagnostic Ultrasound System 989605386721Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 00884838047693), received between Oct 25, 2018 and Sep 17, 2026 — classified as 2 deaths, 2 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (47 reports).

3 FDA recall records 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. Oct 9, 2023Class IICompleted

   Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.

   Z-0283-2024 · Root cause: Software design · Recall details · FDA record ↗

2. 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 ↗

3. Aug 6, 2021Class IICompleted

   Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

   Z-2483-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Integrity Problem

  It was reported the 3D9-3v transducer was leaking oil. The transducer was associated with the EPIQ 7W Ultrasound System. 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 50805638 ↗
• MalfunctionSep 17, 2026Material Integrity Problem

  It was reported the 3D9-3v transducer was leaking oil. The transducer was associated with the EPIQ 7W Ultrasound System. 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 50805491 ↗
• MalfunctionSep 17, 2026Material Integrity Problem

  It was reported the 3D9-3v transducer was leaking oil. The transducer was associated with the EPIQ 7W Ultrasound System. 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 50805035 ↗
• MalfunctionJun 3, 2026Unintended System Motion

  IT WAS REPORTED THAT 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 AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER CLEANED AND RESEATED THE 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. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376408 ↗
• MalfunctionMay 28, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ 7G 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 REPAIRED THE SYSTEM BY RESEATING AND SECURING THE BEARING WHICH ALLOWED 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 THAT 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 25319613 ↗
• MalfunctionMay 26, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ 7G 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 REPAIRED THE SYSTEM BY RESEATING AND SECURING THE BEARING WHICH ALLOWED 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 THAT 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 25281250 ↗
• MalfunctionApr 10, 2026Material Split, Cut or Torn

  A CUSTOMER REPORTED THE C10-3V INTRACAVITY TRANSDUCER EXHIBITED SOME DAMAGE TO THE LENS TIP AREA EXPOSING A PORTION OF THE METAL LAYER UNDERNEATH. THIS PROBE IS ASSOCIATED WITH THE EPIQ 7G ULTRASOUND SYSTEM. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE CUSTOMER'S COMPLAINT WAS ADDRESSED BY PROVIDING INFORMATION FOR A REPLACEMENT TRANSDUCER. 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 24839952 ↗
• InjuryApr 3, 2026Use of Device Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BLEEDING/LACERATION TO THE STOMACH FOLLOWING A TRANSESOPHAGEAL ECHOCARDIOGRAM PROCEDURE WITH THE S7-3T TRANSDUCER AND EPIQ 7C ULTRASOUND SYSTEM. ADDITIONAL INFORMATION IS BEING OBTAINED REGARDING PATIENT OUTCOME. THE TRANSDUCER HAS BEEN REMOVED FROM SERVICE, AND THE PHILIPS SERVICE ENGINEER HAS INITIATED THE REPLACEMENT PROCESS TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERN. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Stomach Ulceration

  MAUDE report 24782360 ↗
• MalfunctionMar 19, 2026Material Separation

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD SEPARATION OF THE LENS FROM THE BODY. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ 7G ULTRASOUND SYSTEM. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. THE SERVICE ENGINEER EVALUATED THE TRANSDUCER, CONFIRMED THE REPORTED PROBLEM AND REPLACED 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 24640215 ↗
• MalfunctionMar 18, 2026Fracture

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ 7G ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF USE; 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 24629699 ↗
• MalfunctionMar 17, 2026Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7C ULTRASOUND SYSTEM¿S CONTROL PANEL SWIVEL MECHANISM 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 REPAIRED THE SYSTEM BY REPLACING THE BUSHING AND CLEANING ALL OTHER MECHANICAL PARTS WHICH ALLOWED 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 THAT 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 24617146 ↗
• MalfunctionMar 11, 2026Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7CULTRASOUND 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 REPAIRED THE SYSTEM BY REPLACING THE BUSHING WHICH ALLOWED 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 24569438 ↗
• MalfunctionMar 6, 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 AND REAFFIXED A 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 24536241 ↗
• MalfunctionMar 5, 2026Material Puncture/Hole

  IT WAS REPORTED THE 3D9-3V TRANSDUCER HAD A PUNCTURE IN THE TIP. THIS WAS ASSOCIATED WITH AN EPIQ 7G ULTRASOUND SYSTEM. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED. THE SERVICE ENGINEER EVALUATED THE TRANSDUCER TO CONFIRM THE REPORTED PROBLEM. 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 24518557 ↗
• MalfunctionMar 4, 2026Unintended System Motion

  IT WAS REPORTED THE SWIVEL MECHANISM OF AN EPIQ 7G 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 ARTICULATION ARM BEARING FLANGE 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 24512895 ↗
• MalfunctionMar 3, 2026Unintended System Motion

  IT WAS REPORTED THAT 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 AS A RESULT OF THE ISSUE. THE PHILIPS SERVICE ENGINEER CLEANED AND RESEATED THE 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. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503344 ↗
• MalfunctionFeb 25, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443721 ↗
• MalfunctionFeb 20, 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. THE ISSUE WAS FOUND OUTSIDE OF USE, THERE WAS NO PATIENT OR USER HARM. 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 24400442 ↗
• MalfunctionFeb 16, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE EPIQ 7C ULTRASOUND SYSTEM, BEING USED WITH AN X8-2T TRANSDUCER, WAS NOT AVAILABLE FOR USE DURING A CABG (CORONARY ARTERY BYPASS GRAFT). THE SYSTEM DISPLAYED AN ERROR MESSAGE AND WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM. A REPLACEMENT X8-2T TRANSDUCER WAS SHIPPED DIRECTLY 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 24345645 ↗
• MalfunctionFeb 5, 2026Unintended System Motion

  A CUSTOMER REPORTED THE CONTROL PANEL ARM ON THEIR EPIQ 7C ULTRASOUND SYSTEM DROPPED RAPIDLY. THERE WAS NO PATIENT OR USER HARM. THE SERVICE ENGINEER REPLACED THE CONTROL PANEL ARM GAS STRUTS 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 24275009 ↗
• MalfunctionJan 20, 2026Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 7 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 24116802 ↗
• MalfunctionJan 15, 2026Fracture

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ 7G ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SERVICE ENGINEER PROVIDED THE CUSTOMER WITH INFORMATION FOR A REPLACEMENT TO ADDRESS 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 24081077 ↗
• MalfunctionJan 15, 2026Unintended System Motion

  A CUSTOMER REPORTED THAT THE SWIVEL MECHANISM OF THE EPIQ 7C ULTRASOUND SYSTEM¿S CONTROL PANEL WILL NOT LOCK INTO POSITION WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. NO PATIENT OR USER WAS HARMED BECAUSE OF THE ISSUE. A PHILIPS SERVICE ENGINEER FOUND THAT THE SOLENOID MOUNTING PLATE SCREWS WERE LOOSENED. THE PHILIPS SERVICE ENGINEER TIGHTENED THE SCREWS ON THE SOLENOID MOUNTING PLATE TO RESOLVE THE CUSTOMER¿S IMMEDIATE ISSUE. NO FURTHER ISSUES WERE 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 24078168 ↗
• MalfunctionDec 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRANSESOPHAGEAL X7-2T TRANSDUCER¿S SILICONE SEAL ON THE FLEXIBLE SHAFT WAS PARTIALLY MISSING. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ 7 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER HAS 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 23937981 ↗
• MalfunctionDec 8, 2025Material Integrity Problem; Material Integrity Problem

  A CUSTOMER REPORTED THEIR C10-3V TRANSDUCER¿S LENS HAD A HOLE, RESULTING IN EXPOSED METAL. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ 7 ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. 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 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 23751372 ↗