FDA Device recall Z-0362-2025
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital i…
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital i… by Topcon Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0362-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-17 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Topcon Medical Systems |
| Distribution | US |
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 posterior ocular measurements to a database of known normal subjects.
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
Identifiers
| code_info | UDI-DI: 04562123288582 Maestro2 Serial Number AB9071330 AB9070792 AB9071375 AB9071843 AB9072242 AB9070148 AB9072017 AB…UDI-DI: 04562123288582 Maestro2 Serial Number AB9071330 AB9070792 AB9071375 AB9071843 AB9072242 AB9070148 AB9072017 AB9071547 AV3071260 AV3071152 AB9071136 AB9070540 AB9072074 AB9071587 AB9072102 AV3070212 AV3070194 AB9071712 AV3071301 AV3070499 AB9072149 AV3071071 AV3071032 AV3071030 AB9070992 AB9071020 AB9070956 AB9072234 AB9072257 AB9071460 AB9071337 AB9070452 AV3070435 AV3070878 AV3070980 AV3071053 AB9070375 AB9071180 AB9070936 AB9071005 AB9070850 AB9071918 AB9071648 AB9071817 AB9071464 AB9071097 AB9070627 AV3070916 AB9070572 AB9070288 AB9070991 AB9070673 AB9071156 AB9070985 AB9071234 AB9071272 AB9070563 AB9071242 AB9071949 AB9072241 AB9071814 AB9072109 AV3070677 AB9070743 AB9070769 AV3070763 AV3070034 AV3070657 AV3070557 AB9070421 AB9070722 AV3070626 AV3070823 AB9070161 AB9070396 AB9070205 AB9071236 AB9071103 AB9070597 AB9072178 AB9072043 AB9071938 AB9071300 AB9070223 AB9072013 AV3070099 AV3070855 AB9070958 AB9070997 AB9070880 AB9071726 AB9071846 AB9072059 AV3070473 AB9071921 AB9 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0362-2025%22
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