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, s…

Recall date

March 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1138-2019

FDA classification

Class II

Brand / firm

Topcon Medical Systems, Inc.

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.