The IMAGEnet 6 Ophthalmic Data System is a software program that is… — Class II medical device recall Z-0362-2025
Ongoing recall by Topcon Medical Systems, Inc., reported 2024-11-20, distributed nationwide. The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "
| Recall number | Z-0362-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Topcon Medical Systems, Inc., Oakland, NJ, United States |
| Recall initiated | 2024-09-17 |
| Classified | 2024-11-12 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 3,144 units |
| UPC / GTIN / UDI-DI | 04562123288582 |
| Serial numbers | AB9070101, AB9070102, AB9070103, AB9070104, AB9070105, AB9070107, AB9070108, AB9070109, AB9070110, AB9070111, AB9070112, AB9070113, AB9070114, AB9070115, AB9070117, AB9070118, AB9070119, AB9070121, AB9070122, AB9070123, AB9070124, AB9070126, AB9070127, AB9070129, AB9070130 and 475 more |
Product
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0362-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.