The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and mana
FDA device recall Z-0362-2025 · posted 2024-11-12 · Open, Classified
Recall details
- Recalling firm
- Topcon Medical Systems, Inc.
- Reason for recall
- 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
- Action taken
- 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
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- NFJ
- Quantity affected
- 3144 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-09-17
- Date posted
- 2024-11-12
- Location
- Oakland, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGEnet6 Ophthalmic Data System (K232828) | Topcon Corporation | 2024-03-01 |