Company: Topcon Medical Systems, Inc.
Date of Enforcement Report: 4/24/2019
Class II:
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.
Recall Number: Z-1138-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Topcon Medical Systems, Inc. on 3/6/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
450 units
DISTRIBUTION
US Nationwide