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 posterior ocular measurements to a database of known normal subjects.
Recall
- Recall Number
- Z-0362-2025
- Event Number
- 95485
- Firm
- Topcon Medical Systems, Inc.
- FEI Number
- 2242863
- Product Code
- NFJ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- September 17, 2024
- Posted
- November 12, 2024
- Address
- 111 Bauer Dr, Oakland, NJ, 07436-3123
Description
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 posterior ocular measurements to a database of known normal subjects.
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
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
US Nationwide distribution.
3144 units