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.
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
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.
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.
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.
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.
Verify if your IMAGEnet 6 software matches the listed serial numbers in the UDI-DI: 04562123288582.
No physical harm is expected. The recall is due to potential misinterpretation in reports, not immediate safety risks.
No. The recall does not require stopping use; it involves potential report misinterpretation that can be corrected.
Check if your software version matches the serial numbers listed in the UDI-DI: 04562123288582.
We’ve drafted a message you can send Topcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0362-2025 — Topcon Topcon Hello, I own a Topcon that is covered by recall Z-0362-2025 from Topcon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
