FUJIFILM BL-7000Recalls & reported problems
Fujifilm Corporation · This device provides illumination to an endoscope and supplies air and water to body cavities via the endoscope, and is intended to provide images captured by the endoscope for endoscopic procedure. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547410337730), received between Apr 26, 2024 and Jul 2, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Image Display Error/Artifact1
- Inflation Problem1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2025Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem
ON JUNE 5TH, 2025 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING BL-7000. IT WAS REPORTED THAT THE STAFF SMELLED SMOKE AND BURNING COMING FROM THE ELUXEO SYSTEM, DURING A TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION DUE TO THE UNCONFIRMED PATIENT IMPACT BY SWITCHING SCOPES DURING THE TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22387151 ↗MalfunctionMay 14, 2024Inflation Problem; Inflation Problem
ON APRIL 15TH, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING BL-7000. IT WAS REPORTED THAT THE INSUFFLATION APPEARS TO BE INCONSISTENT, AS WELL AS IRRIGATION, DURING A TREATMENT. THERE WAS A 20-MINUTES DELAY TO TROUBLESHOOT THE PROCESSER AND THE SCOPE. THERE WAS NO HARM OR INJURY TO THE PATIENT. AS SUCH, THIS REPORT IS BEING SUBMITTED DUE TO DELAY OF PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19307491 ↗MalfunctionApr 26, 2024Image Display Error/Artifact; Image Display Error/Artifact
ON APRIL 4TH 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING BL-7000. IT WAS REPORTED THAT COLORED LINE WAS SEEN ON THE SCREEN, SHUTS OFF AND ON AND SAYS WAIT A WHILE. THE PROCESSOR HAD TO BE CONSTANTLY RESTARTED DURING THE PROCEDURE, DELAYING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT IMPACT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION DUE TO UNKNOWN STATUS OF DELAY. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19197506 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.