Topcon Medical Systems recalls

Topcon Medical Systems has 3 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 20 Nov 2024. 1 is still ongoing. The most frequent reason is device malfunction.

Total recalls3since 2019

Last 12 months0reported

Class I00% of total

Ongoing1latest 20 Nov 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 1 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why topcon medical systems is recalled

Device Malfunction267%
Other Reasons133%

Product types

Test Kits & Diagnostics267%
Other Medical Devices133%

By year

2024133%
2021133%
2019133%

Ongoing topcon medical systems recalls

1 active

Reported	Class	Recall	Company	Reason	Where
20 Nov 2024Device	CLASS II	The IMAGEnet 6 Ophthalmic Data System is recalled	Topcon Medical Systems	Device Malfunction	Nationwide

All topcon medical systems recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
20 Nov 2024Device	CLASS II	The IMAGEnet 6 Ophthalmic Data System is recalled	Topcon Medical Systems	Device Malfunction	Nationwide
10 Feb 2021Device	CLASS II	Harmony Referral System (aka Harmony RS)/ Medical Device Data System recalled	Topcon Medical Systems	Other	6 states
24 Apr 2019Device	CLASS II	IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is recalled	Topcon Medical Systems	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.