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Topcon Medical Systems, Inc.

Topcon Medical Systems, Inc. Recalls

All product recalls associated with Topcon Medical Systems, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Sep 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–2 of 2 recalls

IMAGEnet 6 Ophthalmic System (Topcon) – Probability Map Error (2024)

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

FDASep 17, 2024Nationwide• Topcon Medical Systems, Inc.

Topcon Medical Systems, Inc.: Harmony Referral System (aka Harmony RS)/ Medical Device ...

Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record

FDADec 18, 2020AZ, MO, NY +3 more• Topcon Medical Systems, Inc.