INSPIRA EPK-i8020c (UDI 04961333254910)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333254910), received between Oct 29, 2025 and Oct 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image

  ON 14-SEP-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER F0158Z0062 IN SPAIN WITHIN THE EMEA REGION. THROUGH A GOOD FAITH EFFORT (GFE) CONDUCTED ON 15-OCT-2025, IT WAS CONFIRMED THAT THE INSPECTION RELATED TO THIS EVENT HAD NOT BEEN COMPLETED AT THE TIME OF THE INITIAL REPORT. WHEN USED FOR BLEEDING CASES, THE ENDOSCOPIC IMAGE DISPLAYED BY THE PROCESSOR APPEARED STRONGLY REDDISH. 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 23412835 ↗
• MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image

  ON 03-OCT-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN SPAIN WITHIN THE EMEA REGION. WHEN USED FOR BLEEDING CASES, THE ENDOSCOPIC IMAGE DISPLAYED BY THE PROCESSOR APPEARED STRONGLY REDDISH. 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 23412014 ↗
• MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image

  ON (B)(6) 2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN SPAIN WITHIN THE EMEA REGION. WHEN USED FOR BLEEDING CASES, THE ENDOSCOPIC IMAGE DISPLAYED BY THE PROCESSOR APPEARED STRONGLY REDDISH. 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 23411961 ↗