Z-1138-2019Class II

IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the...

Name: Z-1138-2019 IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the...
Creator: Topcon Medical Systems, Inc.
Published: 2019-03-06
License: https://open.fda.gov/license/

Topcon Healthcare, Inc. / initiated 2019-03-06 / Terminated / root cause: labeling and UDI

FDA source

Topcon Medical Systems, Inc. began a recall of 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... on 2019-03-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1138-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-06
Posted: 2019-04-12
Terminated: 2019-07-17
Recalling firm: Topcon Healthcare, Inc.
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.
Product code: NFJ System, Image Management, Ophthalmic
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Topcon issued Device Correction Notice on 3/22/19 providing problem- there exists a situation in which the displayed patient name and the thumbnail image do not match and action to take.Topcon has corrected this issue in IMAGEnet 6 version 2.0.3 and will be providing a remote upgrade free of charge. Contact customer support team to schedule the upgrade at 866.922.6278 option 1 or by email at [email protected]
Quantity in commerce: 450 units
Distribution: Nationwide
Product codes and lots: System Version 1.53

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1138-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1138-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-12

Product code NFJ

K171370Class IIIMAGEnet 6 Ophthalmic Data SystemTopcon Corporation / cleared 2017-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)