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.
FDA Recall Z-0362-2025 · Posted 2024-11-12
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Recalling FirmTopcon Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodeNFJ
Date Initiated2024-09-17
Product Quantity3144 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
Firm Action
Topcon issued Product and Service Bulletin titled: Important notice regarding changes to
IMAGEnet 6 for Maestro2 users on 9/17/24 via email.
Action Required:
In order to comply with recent FDA requirements, changes have been made to
the Hood Report for Glaucoma on the Maestro2. You must visit our website to
download the software patch for your device. This simple process is designed for customers to complete independently and should take less than 20 minutes to update.
Download Software Patch
For questions or assistance, please contact customer service at
1-866-922-6278 Mon Fri, 8AM-8PM EST
Root Cause
Software design
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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