Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The IMAGEnet 6 Ophthalmic Data System is a software program Recalled by Topcon Medical Systems, Inc. Due to The overlay of visual field test locations on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Topcon Medical Systems, Inc. directly.
Affected Products
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.
Quantity: 3144 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Topcon Medical Systems, Inc.
Topcon Medical Systems, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report