IMAGEnet 6 OPHTHALMIC DATA SYSTEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04562123288582), received between Jan 17, 2019 and Jan 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

1 FDA recall record name this device's identifier, 1 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 16, 2026.

Recalls naming this device

1. Sep 17, 2024Open, Classified

   The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided

   Z-0362-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2019Computer Software Problem; Program or Algorithm Execution Problem; Computer Software Problem; Program or Algorithm Execution Problem

  ON DEC 21, 2018, WE TOPCON CORPORATION RECEIVED AN "ADVERSE INCIDENT REPORT" THAT WAS SUBMITTED FROM A HOSPITAL IN (B)(6) TO (B)(6) REGARDING OUR PRODUCT IMAGENET 6 FROM TOPCON EUROPE MEDICAL (OUR SUBSIDIARY IN (B)(4), OUR MDD REPRESENTATIVE). THEY NOTICED THAT (B)(6) REQUIRED TO SUBMIT A MANUFACTURER'S INCIDENT REPORT TO THEM WITHIN 30 DAYS ON DEC 20, 2018 TO THEM. IN THE HOSPITAL'S "ADVERSE INCIDENT REPORT" FOLLOWING WAS DESCRIBED AS THE INCIDENT. DIAGNOSTIC OCT SCAN VIEWING SOFTWARE HAS A BUG THAT CAN DISPLAY THE SCANS OF A PREVIOUS PATIENT UNDER THE NAME AND DETAILS OF THE FOLLOWING PATIENT. THIS HAS THE POTENTIAL TO SIGNIFICANTLY HARM PATIENTS AS DECISIONS MAY BE MADE ON THE INCORRECT SCANS BEING DISPLAYED. SUCH SCANS ARE USED TO DETERMINE IF A PATIENT REQUIRES INTRAVITREAL INJECTIONS OF DRUGS INTO THE EYE TO PREVENT BLINDNESS DUE TO MACULAR DEGENERATION AND OTHER CONDITIONS. TOPCON INFORMED ON THE 23RD OCTOBER 2018. RECENTLY UPDATED SOFTWARE. PROBLEM IDENTIFIED AS PERSISTING ON THE 17TH DECEMBER 2018. SUCH SOFTWARE WILL BE IT USE IN MULTIPLE EYE DEPARTMENTS IN THE (B)(6) AND OVERSEAS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8258530 ↗