The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection,…
Medical device recall Z-0362-2025. Published in FDA’s Enforcement Report on Nov 20, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 20, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3144 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
3144 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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 AB9070344 AB9072416 AV3070248 AB9071492 AV3070830 AV3071009 AB9070272 AV3070100 AB9070611 AV3070617 AB9071120 AB9071953 AV3070321 AB9071947 AB9070301 AB9070938 AB9072101 AB9072216 AB9070725 AB9072459 AB9070280 AB9071977 AB9071699 AV3071005 AV3070283 AB9070473 AB9070484 AB9072657 AV3070570 AV3071228 AV3071207 AB9071835 AB9071894 AB9071975 AB9071805 AB9071774 AB9070545 AB9070962 AB9071199 AB9071316 AB9071489 AB9072171 AB9071123 AV3070690 AV3070313 AV3071102 AV3070386 AB9071210 AB9071195 AB9070685 AB9071820 AB9071235 AB9072352 AB9070845 AB9072379 AB9072535 AV3070717 AB9072709 AV3070337 AV3071229 AB9070147 AB9070846 AB9070593 AB9071017 AB9072099 AB9072037 AB9071960 AB9072430 AB9070546 AB9071809 AB9072144 AB9071225 AB9070966 AB9071267 AV3070070 AV3071066 AB9071929 AB9072235 AB9071537 AB9071112 AB9070677 AV3071293 AV3070451 AB9072347 AB9070267 AV3070081 AV3071179 AB9071542 AV3070976 AV3071459 AB9072133 AB9072223 AB9071879 AV3070335 AB9072525 AV3070824 AV3071127 AV3071100 AB9070697 AB9072231…
FDA’s list runs to 28,905 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 17, 2024.
- FDA classified it on Nov 12, 2024.
- FDA’s Enforcement Report published it on Nov 20, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Topcon Medical Systems, Inc., of Oakland, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 28,905 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.