Topcon Medical Systems, Inc. recalls
Every recall we track for Topcon Medical Systems, Inc. — 3 in all, from 2019–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
3 recalls since 2017.
All FDA recall records for Topcon Medical Systems, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Topcon Medical Systems, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Topcon Medical Systems, Inc. recalls
3 shown- Lower riskMedical device
Topcon Medical Systems, Inc. recalls The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and
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.
TopconSep 17, 2024 - Lower riskMedical device
Topcon Medical Systems, Inc. recalls Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained
Topcon Medical Systems recalls Harmony RS software version 3.1 due to risk of combining patient records when using with specific medical devices. Affected healthcare professionals should contact for remedy.
Topcon Medical SystemsDec 18, 2020 - Lower riskMedical device
Topcon Medical Systems, Inc. recalls IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection,
Topcon recalls IMAGEnet 6 v1.53 software due to risk of displaying incorrect patient information on screen during use, potentially causing confusion in ophthalmic data systems.
TopconMar 6, 2019
Topcon Medical Systems, Inc. recall questions
How many recalls has Topcon Medical Systems, Inc. had?
3 recalls from Topcon Medical Systems, Inc. are on record with U.S. safety agencies, from 2019–2024.
What is the most recent Topcon Medical Systems, Inc. recall?
Topcon Medical Systems, Inc. recalls The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and, dated Sep 17, 2024. Every Topcon Medical Systems, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Topcon Medical Systems, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Topcon Medical Systems, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.