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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,
Recalled April 24, 2019 · FDA recall Z-1138-2019 · Topcon Medical Systems
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. · FDA Class II
Units
450 units
Sold at
Nationwide
Description
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.
Product
IMAGEnet 6 v1.53- 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 from Topcon devices without controlling or altering the functions and parameters of any medical devices or through computerized networks.
Manufacturer(s)
Topcon Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →