Topcon Medical Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1138-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 6, 2019

Date Posted: April 24, 2019

Recall Number: Z-1138-2019

Event ID: 82322

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.

Status: Terminated

Product Quantity: 450 units

Code Information:

System Version 1.53

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated