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.
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 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.
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.
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.
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.
Verify your software version by looking for the version number in the system settings or documentation.
The recall indicates a potential for incorrect patient information display, which could cause confusion during procedures, but it does not state that the software causes serious injury or death.
The recall does not specify a remedy, so you should check your software version and contact Topcon if you have concerns.
The affected version is IMAGEnet 6 v1.53, which is used for ophthalmic data collection and management systems.
We’ve drafted a message you can send Topcon to request your refund or repair — edit it as you like.
Subject: Recall Z-1138-2019 — Topcon Topcon Hello, I own a Topcon that is covered by recall Z-1138-2019 from Topcon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
