Z-0362-2025.jsonld
type: Dataset
name: 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.
description: FDA recall Z-0362-2025 — Topcon Medical Systems, Inc. is recalling 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. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: 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.
  manufacturer: Topcon Medical Systems, Inc.
claims: enforcement-record
claims: FDA classified recall Z-0362-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0362-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0362-2025
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Topcon Medical Systems, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-09-17
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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 AB90…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0362-2025: Topcon Medical Systems, Inc. is recalling 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.
text: The FDA logged enforcement record Z-0362-2025: Topcon Medical Systems, Inc. is voluntarily recalling 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. Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-17. Affected lots/codes: 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 A…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-0362-2025 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.