Reported Nov 20, 2024 · Ongoing
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and…
Topcon Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Topcon Medical Systems, Inc. · 111 Bauer Dr · Oakland, NJ · 07436-3123
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI04562123288582 Maestro2 Serial Number
2,886 of 2,886 codes
AB9071330AB9070792AB9071375AB9071843AB9072242AB9070148AB9072017AB9071547AV3071260AV3071152AB9071136AB9070540AB9072074AB9071587AB9072102AV3070212AV3070194AB9071712AV3071301AV3070499AB9072149AV3071071AV3071032AV3071030AB9070992AB9071020AB9070956AB9072234AB9072257AB9071460AB9071337AB9070452AV3070435AV3070878AV3070980AV3071053AB9070375AB9071180AB9070936AB9071005AB9070850AB9071918AB9071648AB9071817AB9071464AB9071097AB9070627AV3070916AB9070572AB9070288AB9070991AB9070673AB9071156AB9070985AB9071234AB9071272AB9070563AB9071242AB9071949AB9072241
- UDI-DI04562123288582 Maestro2 Serial Number
- Amount recalled
- 3144 units
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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