# FDA recall Z-0362-2025

> **Topcon Medical Systems, Inc.** · Class II · device recall initiated 2024-09-17.

## 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0362-2025
- **Recalling firm:** Topcon Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-17
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oakland, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0362-2025

## Citation

> AI Analytics. FDA recall Z-0362-2025. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0362-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*