EPIQ Elite Diagnostic Ultrasound System 989606706051Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00884838099111), received between Jan 26, 2021 and Sep 25, 2026 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (16 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Unintended System Motion

  It was reported the control panel arm on an EPIQ Elite Diagnostic Ultrasound System's dropped quickly. The problem 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 50899389 ↗
• MalfunctionJan 28, 2026Fracture

  IT WAS REPORTED THE C10-3V TRANSDUCER HAD A HOLE IN THE LENS WITH EXPOSED ELECTRONICS. THE TRANSDUCER WAS ASSOCIATED WITH AN EPIQ ELITE ULTRASOUND SYSTEM. THIS ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. A REPLACEMENT TRANSDUCER WAS SHIPPED DIRECTLY TO THE CUSTOMER 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 24198615 ↗
• MalfunctionOct 23, 2025Material Separation; Material Separation

  IT REPORTED A 3D9-3V TRANSDUCER HAD SEPARATION ON THE PROBE. THIS PROBE IS ASSOCIATED WITH THE EPIQ ELITE 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 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 23368040 ↗
• MalfunctionSep 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE C10-3V TRANSDUCER FAILED LEAKAGE TESTING. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ ELITE ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE, DURING PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PHILIPS FIELD SERVICE ENGINEER 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 23092586 ↗
• MalfunctionJul 2, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THE EPIQ ELITE ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL RENAL ARTERY EXAM IN THE EMERGENCY DEPARTMENT. 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. 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 22382563 ↗
• MalfunctionJun 2, 2025Unintended 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. A SERVICE ENGINEER PERFORMED A SYSTEM INSPECTION AND TESTED THE CONTROL PANEL LOCKING MECHANISM. THE ISSUE COULD NOT BE REPRODUCED. THE LOCKING MECHANISM WAS WORKING WITHOUT ISSUE, AND NO PROBLEMS WERE OBSERVED. THE SYSTEM HAS BEEN RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128544 ↗
• InjuryFeb 19, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE EPIQ ELITE ULTRASOUND SYSTEM ALONG WITH AN EL18-4 TRANSDUCER WERE PRODUCING IMAGES DURING A BREAST SCAN THAT WERE NOT ABLE TO DIAGNOSE ANECHOIC CYSTS ACCURATELY. PATIENTS HAD UNNECESSARY ASPIRATIONS OF CYSTS. THE CUSTOMER IS CURRENTLY USING AN L12-5 TRANSDUCER AND OBTAINING ADDITIONAL IMAGES TO PREVENT TREATMENT OF ANECHOIC CYSTS. NO FURTHER INFORMATION WAS PROVIDED. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 21412239 ↗
• InjuryFeb 19, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE EPIQ ELITE ULTRASOUND SYSTEM ALONG WITH AN EL18-4 TRANSDUCER WERE PRODUCING IMAGES DURING A BREAST SCAN THAT WERE NOT ABLE TO DIAGNOSE ANECHOIC CYSTS ACCURATELY. PATIENTS HAD UNNECESSARY ASPIRATIONS OF CYSTS. THE CUSTOMER IS CURRENTLY USING AN L12-5 TRANSDUCER AND OBTAINING ADDITIONAL IMAGES TO PREVENT TREATMENT OF ANECHOIC CYSTS. NO FURTHER INFORMATION WAS PROVIDED. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 21411989 ↗
• MalfunctionFeb 6, 2025Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED HAVING CHALLENGES WITH THE 2D IMAGE QUALITY IN THE CALF VEINS; THEY ALLEGED THEY COULD NOT DISTINGUISH A CLOTTED VESSEL FROM A NON-CLOTTED ONE WHEN USING THE EPIQ ELITE ULTRASOUND SYSTEM. ALTHOUGH THERE WAS NO MISDIAGNOSIS AS THE PATIENT HAD A PRIOR EXAM TO COMPARE, THEY COULD NOT DIAGNOSE PROPERLY BASED ON THE STUDY. THERE WAS NO ALLEGATION OF PATIENT/USER HARM, INJURY, OR DEATH. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. A FOLLOW-UP REPORT WILL BE PROVIDED UPON INVESTIGATION COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326989 ↗
• MalfunctionFeb 6, 2025Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED HAVING CHALLENGES WITH THE 2D IMAGE QUALITY IN THE CALF VEINS; THEY ALLEGED THEY COULD NOT DISTINGUISH A CLOTTED VESSEL FROM A NON-CLOTTED ONE WHEN USING THE EPIQ ELITE ULTRASOUND SYSTEM. ALTHOUGH THERE WAS NO MISDIAGNOSIS AS THE PATIENT HAD A PRIOR EXAM TO COMPARE, THEY COULD NOT DIAGNOSE PROPERLY BASED ON THE STUDY. THERE WAS NO ALLEGATION OF PATIENT/USER HARM, INJURY, OR DEATH. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. A FOLLOW-UP REPORT WILL BE PROVIDED UPON INVESTIGATION COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324160 ↗
• MalfunctionAug 6, 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. A PHILIPS SERVICE ENGINEER REALIGNED 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 19924275 ↗
• MalfunctionJul 26, 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. A PHILIPS SERVICE ENGINEER REALIGNED 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 19836423 ↗
• MalfunctionJul 3, 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 FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AND REPLACED THE SOLENOID AND CPA BEARING TO REPLACE THE SYSTEM. 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 19665408 ↗
• MalfunctionMay 10, 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. A PHILIPS SERVICE ENGINEER REALIGNED 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 19292095 ↗
• MalfunctionFeb 28, 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 18797429 ↗
• MalfunctionJan 23, 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 18564480 ↗
• MalfunctionNov 21, 2023Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THAT THE EPIQ ULTRASOUND SYSTEM CONTROL PANEL WAS SWIVELING AND NOT LOCKING. IT IS UNKNOWN IF THE ISSUE WAS DISCOVERED DURING TRANSPORT. THERE WAS NO INJURY OR CLINICAL USE ASSOCIATED WITH THIS EVENT. A PHILIPS SERVICE ENGINEER CLEANED AND ADJUSTED PIN AND SOLENOID. THE SYSTEM WAS PUT BACK INTO SERVICE WITH NO ADDITIONAL ISSUES REPORTED POST REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18186054 ↗
• MalfunctionOct 27, 2023Poor Quality Image; Poor Quality Image

  A CUSTOMER REPORTED THEY WERE NOT SEEING THE NEEDLE TIP DURING LIVER/RENAL INTERVENTIONAL PROCEDURES WITH THE C5-1 TRANSDUCER AND ON THE EPIQ ELITE ULTRASOUND. THE PROCEDURE WAS NOT CONTINUED AND WAS RESCHEDULED. A PHILIPS FIELD SERVICE ENGINEER REPLACED THE SYSTEM HARD DRIVES AND UPDATED THE SYSTEM SOFTWARE TO RESOLVE THIS ISSUE. 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 18025397 ↗
• MalfunctionJun 26, 2023Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE CONTROL PANEL REMAINS UNLOCKED ON THE EPIQ ELITE ULTRASOUND SYSTEM. THE FAILURE OCCURRED WHILE IN CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200047 ↗
• MalfunctionMay 19, 2023Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ ELITE ULTRASOUND SYSTEM¿S CONTROL PANEL WAS UNABLE TO LOCK WHEN ATTEMPTING TO TRANSPORT THE UNIT WITHIN THE USER FACILITY. THEY WERE MOVING THE CART BACK INTO A ROOM, AND WHEN THEY WENT TO ADJUST THE POSITION OF THE CONTROL PANEL, IT WOULD NOT LOCK IN PLACE. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE, AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE REPORTED ISSUE. A PHILIPS SERVICE ENGINEER DETERMINED THE FAILURE WAS CAUSED BY A GREASE BUILD-UP ON THE SMALL PIN ACTUATOR. THE GREASE BUILD-UP IS NOT ALLOWING THE PIN TO LOCK BACK ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963368 ↗
• MalfunctionMay 10, 2023Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THE TOP HALF OF THE EPIQ ELITE ULTRASOUND SYSTEM IS NOT LOCKING, SWIVELS ALL AROUND 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901060 ↗
• MalfunctionApr 13, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THERE WAS A SIGNIFICANT CEUS (CONTRAST-ENHANCED ULTRASOUND) PROBLEM IN NEARFIELD ANECHOIC LESIONS WHEN SCANNING WITH THE EPIQ ELITE ULTRASOUND SYSTEM CONTRAST IST ENHANCED SUCH THAT ANECHOIC LESIONS IN THE B MODE ARE FILLED WITH CONTRAST EVEN THOUGH ONLY A SMALL AMOUNT OF CONTRAST 1.0-1.2ML BOLUS IST USED. THE EXAM BEING PERFORMED WAS AN ABDOMEN, CEUS EXAMINATION, SUPINE. THE MEDICAL INDICATION FOR THIS ULTRASOUND WAS UNCLEAR ABDOMEN WITH CYST. THE CYST WOULD HAVE BEEN OVERLOOKED IF NOT KNOWN BEFORE EXAM. THERE WAS NO MEDICAL INTERVENTION, NO CHANGE IN THE PATIENT¿S STATE OF HEALTH. THE ALLEGED INJURY WAS A DIAGNOSIS THAT ARE NOT PRESENTED AS CHARACTERISTIC. THE USER ALLEGED THE PATIENT¿S SAFETY IS AT RISK WHEN INCORRECT DIAGNOSIS IS MADE DUE TO POOR CEUS QUALITY. THE IMAGE ISSUE WAS DESCRIBED AS: THE CEUS CONTRAST IS SO STRONG IN THE NEARFIELD THAT ANECHOIC LESIONS SUDDENLY APPEAR FILLED WITH CONTRAST MEDIUM OR ARE MASSIVELY SUPERIMPOSED WITH ARTIFACTS. THE EXAM WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731596 ↗
• MalfunctionFeb 16, 2023Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THE CONTROL PANEL IS NOT ABLE TO LOCK ON THEIR EPIQ ELITE ULTRASOUND SYSTEM. IT IS UNKNOWN AT THIS TIME IF THE SYSTEM WAS MOBILE WHEN FAILURE OCCURRED. THERE IS NO DEATH OR SERIOUS INJURY WAS REPORTED. PHILIPS HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION TO NO AVAIL. IF FURTHER INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386932 ↗
• MalfunctionDec 15, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A THYROID MASS APPEARED CYSTIC ON THEIR EPIQ ULTRASOUND MACHINES. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. A FOLLOW UP REPORT WILL BE PROVIDED UPON INVESTIGATION COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986352 ↗
• MalfunctionDec 14, 2022Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED AN EPIQ ELITE ULTRASOUND SYSTEM MISCHARACTERIZED THE INTERNAL LESION RESULTING IN A MISDIAGNOSIS OF CANCER IN A CYST. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. A FOLLOW UP REPORT WILL BE PROVIDED UPON INVESTIGATION COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976104 ↗