Recall Z-0362-2025 ยท NFJ System, Image Management, Ophthalmic
Topcon Medical Systems, Inc.
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
| Date | Nov 12, 2024 (initiated Sep 17, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Software design |
| Action | 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 ES |
| Quantity | 3144 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232828 | IMAGEnet6 Ophthalmic Data System Topcon Corporation, Mar 1, 2024 |