medical Class II Updated 2019-04-24

Topcon Medical Systems, Inc. recalls IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a s

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: System Version 1.53
View official government recall

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