INSPIRA EPK-i8020c (UDI 04961333247974)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04961333247974), received between Nov 5, 2023 and Nov 14, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Data Problem” (8 reports).

2 FDA recall records name this device's identifier, 2 still open.

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 16, 2025Class IIOpen, Classified

   During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.

   Z-2329-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jan 29, 2025Class IIOpen, Classified

   During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

   Z-1238-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Optical Obstruction; Optical Obstruction

  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 23551354 ↗
• MalfunctionJul 3, 2025Optical Obstruction; Optical Obstruction

  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 22391934 ↗
• MalfunctionJun 17, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  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 22216898 ↗
• MalfunctionMay 28, 2025Poor Quality Image; Poor Quality Image

  ON 13-MAY-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN AUSTRALIA WITHIN THE APAC REGION. DURING THE ENDOSCOPIC PROCEDURE, THE ENDOSCOPIC IMAGE TURNED REDDISH AND THEN BECAME DARK. AFTER THE IMAGE DARKENED, THE LIGHT LIMIT MODE OF THE PROCESSOR WAS ENABLED. AT THAT POINT, THE ENDOSCOPE HAD ALREADY REACHED THE ILEOCECAL REGION, MAKING IT DIFFICULT TO CLEAN THE DISTAL END WHILE IT WAS STILL INSIDE THE BODY. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095596 ↗
• MalfunctionMay 14, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  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 22015971 ↗
• MalfunctionFeb 18, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  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 21393141 ↗
• MalfunctionFeb 5, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  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 21309750 ↗
• MalfunctionJan 28, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  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 21249383 ↗
• MalfunctionDec 25, 2024Data Problem; Data Problem

  ERROR IN THE DOCUMENTATION! IF NO NEW PATIENT WAS SELECTED FROM THE WORKLIST BEFORE A NEW EXAMINATION, ALL NEWLY TAKEN PHOTOS ARE NOW AUTOMATICALLY ASSIGNED TO THE LAST SELECTED PATIENT, EVEN THOUGH THIS CASE WAS PROPERLY COMPLETED AND THE ENDOSCOPE WAS REMOVED. THE DISPLAY IN THE PACS VIEWER WAS DOCUMENTED IN A PHOTO. THE PROCESS CAN BE REPRODUCED AT ANY TIME. AN MPPS SERVER HAS NOT YET BEEN USED. NEVERTHELESS, THE POSSIBILITY OF INCORRECT ASSIGNMENT SHOULD BE PREVENTED. WE ARE CURRENTLY STILL WAITING FOR THE CONFORMANCE STATEMENT FROM THE PRACTICE'S DOCUMENTATION SOFTWARE. THIS SHOULD BE DELIVERED LATER. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21015085 ↗
• MalfunctionDec 16, 2024Poor Quality Image; Overheating of Device; Poor Quality Image; Overheating of Device

  B5: THE CONTENT IN THE INITIAL REPORT WAS INSUFFICIENT AND UNCLEAR, SO IT HAS BEEN REVISED AS FOLLOWS. ON 09-DEC-2024 PENTAX MEDICAL BECAME AWARE OF EVENT INVOLVING A MODEL EPK-I8020C, SERIAL NUMBER (B)(6) VIDEO PROCESSOR IN AUSTRALIA WITHIN THE APAC REGION. A USER REPORTED AN ISSUE WHERE ENDOSCOPIC IMAGES TURNED DARK AND RED DURING A PROCEDURE. THE FACILITY USED THE FOLLOWING GASTROSCOPES: - A0038A0455 (EG29-I20C), - Q00Z7AA006 (EG34-I10). BOTH SCOPES EXPERIENCED THE SAME ISSUE, PROMPTING THE USER TO CONTACT A PENTAX MEDICAL REPRESENTATIVE. THEY WERE ADVISED TO USE ANOTHER ENDOSCOPE, BUT THE PROBLEM PERSISTED, REQUIRING A THIRD SCOPE. WHILE THERE WAS NO PHYSICAL HARM TO THE PATIENT, POOR VISIBILITY MADE PROPER OBSERVATION DIFFICULT. THIS RESULTED IN THE NEED FOR MULTIPLE SCOPES, EXTENDING BOTH THE PROCEDURE AND SEDATION TIME BEYOND USUAL. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20936817 ↗
• MalfunctionNov 21, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  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 20742123 ↗
• MalfunctionOct 31, 2024Unintended Movement; Unintended Movement

  PER THE INITIAL REPORT, CUSTOMER WENT TO USE THEIR I10 SCOPES ON A TRAVEL CART FOR A BEDSIDE ICU CASE. HOWEVER, THE VIDEO PROCESSOR IN QUESTION WOULDN'T RECOGNIZE ANY OF THEIR I10 SCOPES. TRIED 3 DIFFERENT SCOPES IN TOTAL, NONE OF WHICH WORKED. DESCRIPTION OF ANY ACTIONS TAKEN: PROCEDURE WAS ABORTED. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20584643 ↗
• MalfunctionOct 31, 2024Unintended Movement; Unintended Movement

  PER THE INITIAL REPORT, CUSTOMER WENT TO USE THEIR I10 SCOPES ON A TRAVEL CART FOR A BEDSIDE ICU CASE. HOWEVER, THE VIDEO PROCESSOR IN QUESTION WOULDN'T RECOGNIZE ANY OF THEIR I10 SCOPES. TRIED 3 DIFFERENT SCOPES IN TOTAL, NONE OF WHICH WORKED. DESCRIPTION OF ANY ACTIONS TAKEN: PROCEDURE WAS ABORTED. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20584621 ↗
• MalfunctionSep 25, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  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 20298915 ↗
• MalfunctionJul 19, 2024No Display/Image; No Display/Image

  INSPIRA PROCESSOR DID NOT RECOGNISE THE DEVICE. THE CUSTOMER INFORMED US BY E-MAIL AS FOLLOWS "IT GOT EVEN WORSE THE OTHER DAY WHEN AN ENDOSCOPY HAD TO BE CARRIED OUT ON A BLEEDING PATIENT IN THE INTENSIVE CARE UNIT AND THE SAME ERROR OCCURRED AGAIN. THE ENDOSCOPY SPECIALIST HAD TO RUN BACK TO THE ENDOSCOPY DEPARTMENT AND FETCH A NEW DEVICE. THIS LOSS OF TIME CAN BE LIFE-THREATENING FOR THE PATIENT." INFORMATION FROM THE HOSPITAL: THERE WAS NO INCIDENT INVOLVING THE PATIENT. A BLEEDING PATIENT WAS TO BE EXAMINED. THE CAUSE OF THE HAEMORRHAGE IS UNKNOWN. FOR THIS REASON, THE EMERGENCY TROLLEY WAS TAKEN TO THE INTENSIVE CARE UNIT. THERE IT WAS DETERMINED THAT THE DEVICE WAS NOT RECOGNISED BY THE PROCESSOR. (BEFORE THE EXAMINATION) ANOTHER DEVICE WAS FETCHED FROM THE ENDOSCOPY DEPARTMENT SOME DISTANCE AWAY, WHICH LED TO A TIME DELAY. EXACTLY THIS TIME DELAY CAN BE LIFE-THREATENING. THE DEFECTIVE PROCESSOR IS OUR LOANER EPKI-8020C B0023Z0223 THE SERIES OF ENDOSCOPES USED IS THE I20C SERIES. I DO NOT KNOW THE SOFTWARE STATUS. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. B3:NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785789 ↗
• MalfunctionFeb 12, 2024Unintended Movement; Unintended Movement

  DURING THE PROCEDURE THE ENDOSCOPE IMAGE WAS LOST MULTIPLE TIMES DURING THE PROCEDURE. VIDEO PROCESSOR VIDEO OUTPUT WAS NOT LOST. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692254 ↗
• MalfunctionFeb 5, 2024No Display/Image; Unintended Movement; No Display/Image; Unintended Movement

  DURING THE PROCEDURE THE ENDOSCOPE IMAGE WAS LOST MULTIPLE TIMES DURING THE PROCEDURE. VIDEO PROCESSOR VIDEO OUTPUT WAS NOT LOST. ENODSCOPE SERIAL NUMBER: (B)(6) WAS USED FOR TESTING. (NO PATIENT USE). MOVING THE SCOPE CONNECTOR SIDE TO SIDE AND UP, DOWN. THE ENDOSOCPE IMAGE WAS LOST BUT THE PROCESSOR SHOWED THAT THE SCOPE WAS STILL CONNECTED REGISTERED. ENDOSCOPE WAS DISCONNECTED AND RECONNECTED WHEN IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH THE SAME SCOPE ON BOTH OCCURRENCES. PROCEDURE TOOK LONGER THAN REQUIRED. NO OTHER IMPACT TO PATIENT. EXAMINATION WAS COMPLETED. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647485 ↗
• MalfunctionNov 6, 2023Data Problem; Patient Data Problem; Data Problem; Patient Data Problem

  ACCORDING TO IT SUPPORT, THE IMAGES STORED BY INSPIRA ARE NOT DICOM-COMPLIANT; THERE ARE INCORRECT ASSIGNMENTS OF IMAGES TO PATIENTS OR STORAGE PROBLEMS. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080916 ↗
• MalfunctionNov 6, 2023Data Problem; Patient Data Problem; Data Problem; Patient Data Problem

  AFTER SUCCESSFUL INSTALLATION OF THE DICOM DOCUMENTATION, THERE ARE MASSIVE PROBLEMS WITH THE DICOM TRANSFER FROM THE PENTAX PROCESSOR TO THE GI VIEWPOINT DOCUMENTATION SOFTWARE DURING OPERATION. PICTURES ARE ASSIGNED TO THE WRONG PATIENTS.TRANSMISSIONS SOMETIMES TAKE >24 HOURS OR DISAPPEAR COMPLETELY. (B)(4) OF DEKOM ASSUMES A DATA COLLISION OF THE 4 INSPIRA PROCESSORS USED SIMULTANEOUSLY IN THE NETWORK. THE SYSTEM CANNOT BE USED WITH THIS ERROR AND IS A RISK FOR THE PATIENT DUE TO POSSIBLE INCORRECT ASSIGNMENTS! THE PENTAX DICOM SOFTWARE IS MISSING A TIME STAMP AND THEREFORE DATA COLLISIONS CAN / DO OCCUR WHEN USING OTHER PROCESSORS IN THE NETWORK. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080915 ↗
• MalfunctionNov 6, 2023Data Problem; Patient Data Problem; Data Problem; Patient Data Problem

  AFTER SUCCESSFUL INSTALLATION OF THE DICOM DOCUMENTATION, THERE ARE MASSIVE PROBLEMS WITH THE DICOM TRANSFER FROM THE PENTAX PROCESSOR TO THE GI VIEWPOINT DOCUMENTATION SOFTWARE DURING OPERATION. PICTURES ARE ASSIGNED TO THE WRONG PATIENTS.TRANSMISSIONS SOMETIMES TAKE >24 HOURS OR DISAPPEAR COMPLETELY. (B)(4) OF DEKOM ASSUMES A DATA COLLISION OF THE 4 INSPIRA PROCESSORS USED SIMULTANEOUSLY IN THE NETWORK. THE SYSTEM CANNOT BE USED WITH THIS ERROR AND IS A RISK FOR THE PATIENT DUE TO POSSIBLE INCORRECT ASSIGNMENTS! THE PENTAX DICOM SOFTWARE IS MISSING A TIME STAMP AND THEREFORE DATA COLLISIONS CAN / DO OCCUR WHEN USING OTHER PROCESSORS IN THE NETWORK. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080912 ↗
• MalfunctionNov 6, 2023Data Problem; Patient Data Problem; Data Problem; Patient Data Problem

  AFTER SUCCESSFUL INSTALLATION OF THE DICOM DOCUMENTATION, THERE ARE MASSIVE PROBLEMS WITH THE DICOM TRANSFER FROM THE PENTAX PROCESSOR TO THE GI VIEWPOINT DOCUMENTATION SOFTWARE DURING OPERATION. PICTURES ARE ASSIGNED TO THE WRONG PATIENTS.TRANSMISSIONS SOMETIMES TAKE >24 HOURS OR DISAPPEAR COMPLETELY. MR. KLUBER OF DEKOM ASSUMES A DATA COLLISION OF THE 4 INSPIRA PROCESSORS USED SIMULTANEOUSLY IN THE NETWORK. THE SYSTEM CANNOT BE USED WITH THIS ERROR AND IS A RISK FOR THE PATIENT DUE TO POSSIBLE INCORRECT ASSIGNMENTS! THE PENTAX DICOM SOFTWARE IS MISSING A TIME STAMP AND THEREFORE DATA COLLISIONS CAN / DO OCCUR WHEN USING OTHER PROCESSORS IN THE NETWORK. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080911 ↗
• MalfunctionNov 5, 2023Data Problem; Data Problem

  AFTER SUCCESSFUL INSTALLATION OF THE DICOM DOCUMENTATION, THERE ARE MASSIVE PROBLEMS WITH THE DICOM TRANSFER FROM THE PENTAX PROCESSOR TO THE GI VIEWPOINT DOCUMENTATION SOFTWARE DURING OPERATION. PICTURES ARE ASSIGNED TO THE WRONG PATIENTS.TRANSMISSIONS SOMETIMES TAKE 24 HOURS OR DISAPPEAR COMPLETELY. DEKOM MEDICAL CONTACT PERSON ASSUMES A DATA COLLISION OF THE 4 INSPIRA PROCESSORS USED SIMULTANEOUSLY IN THE NETWORK. THE SYSTEM CANNOT BE USED WITH THIS ERROR AND IS A RISK FOR THE PATIENT DUE TO POSSIBLE INCORRECT ASSIGNMENTS! THE PENTAX DICOM SOFTWARE IS MISSING A TIME STAMP AND THEREFORE DATA COLLISIONS CAN / DO OCCUR WHEN USING OTHER PROCESSORS IN THE NETWORK. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070786 ↗
• MalfunctionNov 5, 2023Data Problem; Data Problem

  THERE IS A PROBLEM WITH DICOM AND THE INTERNAL SYSTEM OF THE PROCESSOR. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070785 ↗
• MalfunctionNov 5, 2023Data Problem; Data Problem

  THERE IS A PROBLEM WITH DICOM AND THE INTERNAL PROCESSOR SYSTEM. THIS EVENT OCCURRED AT THE TIME OF INSTALLATION. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070784 ↗