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Topcon Medical Systems Recalls
3 recalls on record · April 24, 2019 to November 20, 2024 · Medical Devices
Recalls by year
19
21
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 20, 2024Medical DevicesFDA
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 man
Hazard: 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
February 10, 2021Medical DevicesFDA
Topcon Medical Systems, Inc. recalls Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained he
Hazard: 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
April 24, 2019Medical DevicesFDA
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,
Hazard: When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's ID, etc. on the monitor screen of the PC used.