Topcon IMAGEnet 6 Ophthalmic Data System Software Recall: Incorrect Visual Field Analysis
Topcon recalls IMAGEnet 6 software for ophthalmic data systems due to potential incorrect visual field analysis in reports. This software is used with Topcon devices for eye health imaging. No specific remedy is listed in the recall notice.
Lower-risk 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
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What happened, in plain English
Topcon is recalling its IMAGEnet 6 Ophthalmic Data System software, which is used for eye health imaging. The recall is due to a potential risk in how visual field test results are presented in reports, which could imply incorrect structure-function correlations without clinical evidence. This does not involve physical harm but requires software correction. Read more at govinfonow.com/recall/54013-topcon-imagenet-6-ophthalmic-data-system-software-recall-incorrect-visual.
Source Summary by GovInfoNow · govinfonow.com/recall/54013-topcon-imagenet-6-ophthalmic-data-system-software-recall-incorrect-visual · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0362-2025
Cite this page
“Topcon IMAGEnet 6 Ophthalmic Data System Software Recall: Incorrect Visual Field Analysis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54013-topcon-imagenet-6-ophthalmic-data-system-software-recall-incorrect-visual. Based on FDA recall #Z-0362-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0362-2025%22&limit=1).
Why it’s dangerous
The software's 'Hood Report' feature overlays visual field test locations on probability maps. This presentation could incorrectly suggest structure-function correlations for which clinical evidence is not provided, potentially leading to misinterpretation of eye health data.
Who’s affected
Ophthalmologists and eye care professionals who use Topcon devices with the IMAGEnet 6 software for eye health imaging. The risk is low as it relates to potential misinterpretation in reports, not physical injury.
How to tell if you have this one
The IMAGEnet 6 Ophthalmic Data System software, used with Topcon devices for eye health imaging. The recall includes specific serial numbers listed in the UDI-DI: 04562123288582. Check if your software version matches the listed serial numbers.
- Brand
Topcon- Category
Medical device
What to do — step by step
Check Software Version
Verify if your IMAGEnet 6 software matches the listed serial numbers in the UDI-DI: 04562123288582.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this software?
No. The recall does not require stopping use; it involves potential report misinterpretation that can be corrected.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0362-2025 (September 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0362-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.