IMAGINA EPK-i5500cRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04961333232918), received between Jul 7, 2021 and Feb 8, 2024 — classified as 30 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (8 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Optical Obstruction; Optical Obstruction

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY ).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18665388 ↗
• MalfunctionDec 18, 2023Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18342681 ↗
• MalfunctionSep 14, 2022No Display/Image; Failure to Power Up; No Display/Image; Failure to Power Up

  CUSTOMER REPORTED THAT A DOUBLE PROCEDURE WAS BEING PERFORMED AND IN BETWEEN THE EGD AND THE COLONOSCOPY, WHILE THE TECH WAS DOING BEDSIDE PRE-CLEAN OF THE EGD SCOPE, THE PROCESSOR WENT INTO SLEEP MODE ON IT'S OWN. THE TOUCH PANEL AND PROCEDURE MONITORS WENT COMPLETELY BLACK. FORTUNATELY THIS INCIDENT OCCURRED WHILE THE SCOPE WAS OUTSIDE OF THE PATIENT. THEY WERE ABLE TO PRESS THE POWER BUTTON AND BRING UP THE PROCESSOR AND MONITORS. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415729 ↗
• MalfunctionSep 14, 2022No Display/Image; Failure to Power Up; No Display/Image; Failure to Power Up

  CUSTOMER REPORTED THAT A DOUBLE PROCEDURE WAS BEING PERFORMED AND IN BETWEEN THE EGD AND THE COLONOSCOPY, WHILE THE TECH WAS DOING A BEDSIDE PRE-CLEAN OF THE EGD SCOPE, THE PROCESSOR WENT INTO SLEEP MODE ON IT'S OWN. THE TOUCH PANEL AND PROCEDURE MONITORS WENT COMPLETELY BLACK. PER LARRY LEINS (PENTAX SALES), THIS OCCURRED WHILE CHRIS AND I WERE AT THE SITE, AND WE WERE TOLD THAT THEY EXACT SAME THING HAD HAPPENED ON MONDAY IN THEIR OTHER PROCEDURE ROOM. FORTUNATELY THIS INCIDENT OCCURRED WHILE THE SCOPE WAS OUTSIDE OF THE PATIENT. THEY WERE ABLE TO PRESS THE POWER BUTTON AND BRING UP THE PROCESSOR AND MONITORS. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415726 ↗
• MalfunctionMar 2, 2022Poor Quality Image; Poor Quality Image

  THERE WAS NO REPORT OF PATIENT HARM. THE TIME OF EVENT IS UNKNOWN. NO KNOWN ADVERSE EVENT. REFER TO EXPIRATION DATE AS COMPLAINT NOTIFICATION DATE. CUSTOMER REPORTED HE & HIS OTHER PHYSICIANS HAVE NOTICED A SLOW DETERIORATION OF IMAGE QUALITY SINCE THE INSTALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657044 ↗
• MalfunctionDec 17, 2021No Display/Image; Optical Problem; No Display/Image; Optical Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) REGION INVOLVING PENTAX VIDEO PROCESSOR EPK-I5500CL. IN THE EVENT REPORTED, THE USER STATES THAT THE SALES REP UPGRADED THE FIRMWARE YESTERDAY ON 20 SCOPES AT (B)(6) AFTER THEY COMPLETED PROCEDURES. THE PHYSICIAN CALLED HIM TO SAY THAT THEY'VE BEEN HAVING PROBLEMS ALL MORNING, WITH VARIOUS SCOPES, IN ROOM 3 - THE ROOM THAT SALES PERSONNEL USED TO UPGRADE THE FIRMWARE OF ALL SCOPES. THE ISSUES HAVE BEEN IMAGE FREEZING, FLASHING, AND/OR GOING BLACK ALTOGETHER AND WOULD HAPPEN MULTIPLE TIMES PER PROCEDURE. IT IS OCCURRING IN EACH PROCEDURE SO FAR THIS MORNING.. THE TIMING OF THE EVENT IS IN THE PROCEDURE ROOM DURING USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027647 ↗
• MalfunctionDec 15, 2021No Display/Image; Optical Problem; No Display/Image; Optical Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO PROCESSOR EPK-I5500CL. IN THE EVENT REPORTED, THE USER STATES THAT THE SALES REP UPGRADED THE FIRMWARE YESTERDAY ON 20 SCOPES AT (B)(6) AFTER THEY COMPLETED PROCEDURES. THE PHYSICIAN CALLED HIM TO SAY THAT THEY'VE BEEN HAVING PROBLEMS ALL MORNING, WITH VARIOUS SCOPES, IN ROOM 3 - THE ROOM THAT SALES PERSONNEL USED TO UPGRADE THE FIRMWARE OF ALL SCOPES. THE ISSUES HAVE BEEN IMAGE FREEZING, FLASHING, AND/OR GOING BLACK ALTOGETHER AND WOULD HAPPEN MULTIPLE TIMES PER PROCEDURE. IT IS OCCURRING IN EACH PROCEDURE SO FAR THIS MORNING.. THE TIMING OF THE EVENT IS IN THE PROCEDURE ROOM DURING USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009033 ↗
• MalfunctionDec 15, 2021No Display/Image; Optical Problem; No Display/Image; Optical Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) INVOLVING PENTAX VIDEO PROCESSOR EPK-I5500CL. IN THE EVENT REPORTED, THE USER STATES THAT THE SALES REP UPGRADED THE FIRMWARE YESTERDAY ON 20 SCOPES AT DUKE BRIER CREEK AFTER THEY COMPLETED PROCEDURES. THE PHYSICIAN CALLED HIM TO SAY THAT THEY'VE BEEN HAVING PROBLEMS ALL MORNING, WITH VARIOUS SCOPES, IN ROOM 3 - THE ROOM THAT SALES PERSONNEL USED TO UPGRADE THE FIRMWARE OF ALL SCOPES. THE ISSUES HAVE BEEN IMAGE FREEZING, FLASHING, AND/OR GOING BLACK ALTOGETHER AND WOULD HAPPEN MULTIPLE TIMES PER PROCEDURE. IT IS OCCURRING IN EACH PROCEDURE SO FAR THIS MORNING. THE TIMING OF THE EVENT IS IN THE PROCEDURE ROOM DURING USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009032 ↗
• MalfunctionDec 15, 2021No Display/Image; Optical Problem; No Display/Image; Optical Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO PROCESSOR EPK-I5500CL. IN THE EVENT REPORTED, THE USER STATES THAT THE SALES REP UPGRADED THE FIRMWARE YESTERDAY ON 20 SCOPES AT (B)(6) AFTER THEY COMPLETED PROCEDURES. THE PHYSICIAN CALLED HIM TO SAY THAT THEY'VE BEEN HAVING PROBLEMS ALL MORNING, WITH VARIOUS SCOPES, IN ROOM 3 - THE ROOM THAT SALES PERSONNEL USED TO UPGRADE THE FIRMWARE OF ALL SCOPES. THE ISSUES HAVE BEEN IMAGE FREEZING, FLASHING, AND/OR GOING BLACK ALTOGETHER AND WOULD HAPPEN MULTIPLE TIMES PER PROCEDURE. IT IS OCCURRING IN EACH PROCEDURE SO FAR THIS MORNING.THE TIMING OF THE EVENT IS IN THE PROCEDURE ROOM DURING USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009031 ↗
• MalfunctionDec 15, 2021No Display/Image; Optical Problem; No Display/Image; Optical Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO PROCESSOR EPK-I5500CL. IN THE EVENT REPORTED, THE USER STATES THAT THE SALES REP UPGRADED THE FIRMWARE YESTERDAY ON 20 SCOPES AT (B)(6) AFTER THEY COMPLETED PROCEDURES. THE PHYSICIAN CALLED HIM TO SAY THAT THEY'VE BEEN HAVING PROBLEMS ALL MORNING, WITH VARIOUS SCOPES, IN ROOM 3 - THE ROOM THAT SALES PERSONNEL USED TO UPGRADE THE FIRMWARE OF ALL SCOPES. THE ISSUES HAVE BEEN IMAGE FREEZING, FLASHING, AND/OR GOING BLACK ALTOGETHER AND WOULD HAPPEN MULTIPLE TIMES PER PROCEDURE. IT IS OCCURRING IN EACH PROCEDURE SO FAR THIS MORNING.. THE TIMING OF THE EVENT IS IN THE PROCEDURE ROOM DURING USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009020 ↗
• MalfunctionAug 23, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PENTAX MEDICAL SERVICE IN THE USA INSPECTED PENTAX MODEL EPK-I5500C/SERIAL (B)(4) AND CONFIRMED THE FOLLOWING: SCOPE CONNECTOR UNIT ENDOSCOPE IMAGE FREEZES, SCOPE CONNECTOR UNIT INTERMITTENT CONNECTION. PENTAX SERVICE REPLACED THE ELECTRICAL CONNECTOR, APPLIED A SOFTWARE UPDATE AND PERFORMED RE-ALIGNMENT. THE DEVICE WAS RETURNED TO THE LOANER INVENTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354294 ↗
• MalfunctionAug 23, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PENTAX MEDICAL SERVICE IN THE USA INSPECTED PENTAX MODEL EPK-I5500C/SERIAL(B)(4) AND CONFIRMED THE FOLLOWING: SCOPE CONNECTOR UNIT ENDOSCOPE IMAGE FREEZES. PENTAX SERVICE REPLACED THE CPU BOARD AND FPGA BOARD ASSY. THE DEVICE WAS RETURNED TO THE LOANER INVENTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354290 ↗
• MalfunctionAug 5, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BUG AT THE LANGUAGE SELECTION ON THE TOUCH SCREEN. A SMALL PROBLEM ON THE SELECTION OF PROFILES "MAX/MIN" ON THE EPK-I5500C, THE PROFILE "MIN" REMAINS IN ENGLISH, EVEN IF YOU SELECTED FRENCH FOR THE PROFILE "MAX". YOU ARE OBLIGED TO RE-SELECT FRENCH FOR THE "MIN" PROFILE FOR IT TO APPEAR IN FRENCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278855 ↗
• MalfunctionAug 4, 2021No Display/Image; No Display/Image

  THIS EVENT OCCURRED BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE PROCESSOR CANNOT BOOT OPERATING SYSTEM AND TOUCH SCREEN STAYS BLACK PERMANENTLY. SERVICE FOUND OUT IT'S DEFECTIVE CPU BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272352 ↗
• MalfunctionAug 4, 2021Patient Data Problem; Patient Data Problem

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. ENTRY OF PATIENT DATA NOT POSSIBLE. ERROR MESSAGE: AN ERROR OCCURRED DURING INITIALIZATION OF PATIENT DATABASE, AND ADDITIONAL SYSTEM ERROR 002-0006(PATIENT_DATABASE_ERROR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272347 ↗
• MalfunctionAug 3, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 22-JAN-2021 INVOLVING PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I5500C-US, SERIAL NUMBER (B)(4) WITH THE DESCRIPTION OF "TAKES DOZENS OF PICTURES INTERMITTENTLY, FREEZES AND BLACKS OUT DURING PROCEDURES." THE UNIT WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 28-JAN-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED THE "SCOPE CONNECTOR INTERMITTENT ENDOSCOPE SIGNAL" AND "SCOPE CONNECTOR UNIT STORAGE RECEPTACLE MISALIGNED" ON 28-JAN-2021. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: GLOBAL RECEPTACLE. PENTAX MEDICAL MODEL EPK-I5500C, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 11-FEB-2020. THE DEVICE WAS REPAIRED AND APPROVED BY FINAL QC ON 28-JAN-2021 AND RETURNED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267899 ↗
• MalfunctionJul 31, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. ALL MERCHANDISE EPK-I5500C IMAGINA PROCESSOR HAVE TO BE CHECK TO ENSURE THEY HAVE THE LATEST SOFTWARE. UPON CHECKING THE VIDEO IMAGE OF THE PROCESSOR, THE ENDOSCOPE VIDEO IMAGE FREEZES AFTER A SLIGHT MOVEMENT ON THE SCOPE HOUSING CONNECTOR, CAUSING INTERMITTENT SIGNAL CONNECTION TO THE VIDEO IMAGE DUE TO THE SCOPE RECEPTACLE BEING MISALIGNED/LOOSE. DESCRIPTION OF ANY ACTIONS TAKEN: CURRENTLY HOLD IN VIDEO DEPT. AND SYSTEM FOR FURTHER EVALUATION. PRODUCT MANAGER HAS BEEN INFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257137 ↗
• MalfunctionJul 31, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. ERROR ON THE DISPLAY : AN ERROR OCCURRED DURING INITIALIZATION OF PATIENT DATABASE; SYSTEM ERROR 002-0006.(PATIENT_DATABASE_ERROR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257133 ↗
• MalfunctionJul 30, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. IMAGE FREEZE WHEN SUCTION TUBING DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250899 ↗
• MalfunctionJul 30, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. IMAGE FREEZE WHEN SUCTION TUBING DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250897 ↗
• MalfunctionJul 30, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THIS EVENT OCCURRED AT THE TIME OF INSTALLATION. THERE WAS NO REPORT OF PATIENT HARM. DURING INSTALLATION IT WAS FOUND THAT DVI HAS NO OUTPUT, ALL OTHER ANALOG OUTPUTS HAVE IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250877 ↗
• MalfunctionJul 30, 2021Circuit Failure; Circuit Failure

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE LED IS ON EVEN THOUGH THE BUTTON AN THE PROCESSOR IS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250874 ↗
• MalfunctionJul 29, 2021Unintended System Motion; Unintended System Motion

  IT IS A PROCESSOR THAT TAKES DOZENS OF PICTURES INTERMITTENTLY, FREEZES, AND BLACKS OUT DURING PROCEDURES. USER TOLD THAT THE PROBLEM IS IN THE RECEPTACLE ON THE PROCESSOR. THERE WAS NO REPORT OF PATIENT HARM. DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243729 ↗
• MalfunctionJul 27, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  WHEN WE PREPARED THE DEMO, WE TESTED ALL THE FUNCTIONS. IT WAS NORMAL. HOWEVER, WHEN THE DOCTOR CAME, SUDDENLY, THE TOUCH PANEL IS NOT WORKING. THE SCREEN WAS FROZE. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230345 ↗
• MalfunctionJul 27, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IMAGINA PROCESSOR "FREEZING". THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230336 ↗