Z-1138-2019 Class II Terminated

Recalled by Topcon Medical Systems, Inc. — Oakland, NJ

Recall Details

Product Type
Devices
Report Date
April 24, 2019
Initiation Date
March 6, 2019
Termination Date
July 17, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
450 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

System Version 1.53