Topcon IMAGEnet 6 v1.53 Software Recall: Patient Data Display Hazard
Topcon recalls IMAGEnet 6 v1.53 software due to risk of displaying incorrect patient information on screen during use, potentially causing confusion in ophthalmic data systems.
Lower-risk 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.
Contact the company
What happened, in plain English
Topcon is recalling its IMAGEnet 6 v1.53 software version because it can display secondary patient information on the screen while viewing a primary patient's data. This could lead to confusion during medical procedures, especially when multiple patients are involved. Read more at govinfonow.com/recall/68909-topcon-imagenet-6-v1-53-software-recall-patient-data-display.
Source Summary by GovInfoNow · govinfonow.com/recall/68909-topcon-imagenet-6-v1-53-software-recall-patient-data-display · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1138-2019
Cite this page
“Topcon IMAGEnet 6 v1.53 Software Recall: Patient Data Display Hazard.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68909-topcon-imagenet-6-v1-53-software-recall-patient-data-display. Based on FDA recall #Z-1138-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1138-2019%22&limit=1).
Why it’s dangerous
The software may show secondary patient details (like name and ID) on the screen while viewing a primary patient's data. This could cause medical staff to accidentally use the wrong patient's information during procedures, potentially leading to confusion or errors.
Who’s affected
Ophthalmologists and medical staff using Topcon's IMAGEnet 6 v1.53 software for patient data management are most at risk of confusion during procedures due to incorrect patient information display.
How to tell if you have this one
The affected software is version 1.53 of IMAGEnet 6 Ophthalmic Data System from Topcon Medical Systems, Inc. This version was sold for ophthalmic data collection and management systems.
- Brand
Topcon- Category
Medical device
What to do — step by step
Check Software Version
Verify your software version by looking for the version number in the system settings or documentation.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1138-2019 (March 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1138-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.