Topcon Medical Systems, Inc.: Device Recall

Recall #Z-0362-2025 · 09/17/2024

Class II: Risk

Recall Details

Recall Number: Z-0362-2025
Classification: Class II
Product Type: Device
Recalling Firm: Topcon Medical Systems, Inc.
Status: Ongoing
Date Initiated: 09/17/2024
Location: Oakland, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3144 units

Reason for Recall

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

Product Description

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.

Distribution Pattern

US Nationwide distribution.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.