IMAGEnet 6 Ophthalmic System (Topcon) – Probability Map Error (2024)
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According to the U.S. Food and Drug Administration (FDA)
Product
The 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. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of poster
Brand
Topcon Medical Systems, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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Topcon Medical Systems, Inc. is recalling The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collecti due to The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided
Recommended Action
Per FDA guidance
Topcon issued Product and Service Bulletin titled: Important notice regarding changes to IMAGEnet 6 for Maestro2 users on 9/17/24 via email. Action Required: In order to comply with recent FDA requirements, changes have been made to the Hood Report for Glaucoma on the Maestro2. You must visit our website to download the software patch for your device. This simple process is designed for customers to complete independently and should take less than 20 minutes to update. Download Software Patch For questions or assistance, please contact customer service at 1-866-922-6278 Mon Fri, 8AM-8PM EST
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026