Recall – Patient data system may display incorrect information

Company: Topcon Medical Systems, Inc.
Date of Enforcement Report: 4/24/2019
Class II:


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


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.


Topcon Medical Systems, Inc. on 3/6/2019. Voluntary: Firm Initiated recall is ongoing.

450 units


US Nationwide

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.