Topcon Medical Systems, Inc. recalls The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and man…

Recall date

September 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0362-2025

FDA classification

Class II

Brand / firm

Topcon Medical Systems, Inc.

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.