Drug recall
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection…
FDA recall event 95485 · Class II · Topcon Medical Systems, Inc.
Key facts
| Event ID | 95485 |
|---|---|
| Recall numbers | Z-0362-2025 |
| Recalling firm | Topcon Medical Systems, Inc. |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 17, 2024 |
| Report date | Nov 20, 2024 |
| City | Oakland |
| State | NJ |
| Country | United States |
| FEI number | 2242863 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: