{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2620-2024.jsonld", "@type": "schema:Dataset", "name": "Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.", "description": "FDA recall Z-2620-2024 — DKK Dai-Ichi Shomei Co., Ltd. is recalling Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. (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/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2620-2024&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.", "manufacturer": { "@type": "schema:Organization", "name": "DKK Dai-Ichi Shomei Co., Ltd." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2620-2024/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-2620-2024: DKK Dai-Ichi Shomei Co., Ltd. is recalling Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.", "text": "The FDA logged enforcement record Z-2620-2024: DKK Dai-Ichi Shomei Co., Ltd. is voluntarily recalling Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. — reason: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-09. Affected lots/codes: Model Number: AUT7-LH/TV-LH; Serial Numbers: 13040011, 13040012, 13040013, 13040014, 13040015, 13040016, 13040017, 13040018, 13040019, 13040020, 13040021, 13040022, 13040023, 13040024, 13070025, 13070026, 13070027, 13070028, 13070029, 13070030, 13070031, 13070032, 13070033, 13070034, 13070035, 13070036, 13070037, 13070038, 13070039, 13070040, 13070041, 13070042, 13070043, 13080044, 13080045, 13080046, 13080047, 13080048, 13080049, 13080050, 13080051, 13080052, 13080053, 13090054, 13090055, 13090056, 13090057, 13090058, 13090059, 13090060, 13090061, 13090062, 13090063, 13090064, 13090065, 13090066, 13090067, 13090068, 13090069, 13090070, 13090071, 13090072, 13090073, 13090074, 13090075, 13090076, 13090077, 13100078, 13100079, 13100080, 13100081, 13100082, 13100083, 13100084, 13100085, 13100086, 13100087, 13100088, 13100089, 13100090, 13100091, 13100092, 13100093, 13100094, 13100095, 13100096, 13100097, 13110098, 13110099, 13110100, 13110101, 13110102, 13110103, 13110104, 13110105, 13110106, 13110107, 13110108, 13110109, 13110110, 13110111, 13120112, 13120113, 13120114, 14010115, 14010116, 14010117, 14010118, 14010119, 14010120, 14010121, 14010122, 14010123, 14010124, 14010125, 14010126, 14010127, 14010128, 14010129, 14010130, 14010131, 14010132, 14010133, 14020134, 14020135, 14020136, 14020137, 14020138, 14020139, 14020140, 14020141, 14020142, 14020143, 14020144, 14020145, 14020146, 14020147, 14020148, 14020149, 14020150, 14020151, 14020152, 14020153, 14030154, 14030155, 14030156, 14030157, 14030158, 14030159, 14030160, 14030161, 14030162, 14030163, 14030164, 14030165, 14030166, 14030167, 14030168, 14030169, 14030170, 14030171, 14030172, 14030173, 14040174, 14040175, 14040176, 14040177, 14040178, 14040179, 14040180, 14040181, 14040182, 14040183, 14040184, 14040185, 14040186, 14040187, 14040188, 14040189, 14040190, 14040191, 14040192, 14040193, 14040194, 14040195, 14040196, 14040197, 14040198, 14040199, 14040200, 14040201, 14040202, 14040203, 14040204, 14040205, 14040206, 14040207, 14040208, 14040209, 14040210, 14040211, 14040212, 14040213, 14050214, 14050215, 14050216, 14050217, 14050218, 14050219, 14050220, 14050221, 14050222, 14050223, 14050224, 14050225, 14050226, 14050227, 14050228, 14050229, 14050230, 14050231, 14050232, 14050233, 14050234, 14050235, 14050236, 14050237, 14050238, 14050239, 14050240, 14050241, 14050242, 14050243, 14050244, 14050245, 14050246, 14050247, 14050248, 14050249, 14050250, 14050251, 14050252, 14050253, 14060254, 14060255, 14060256, 14060257, 14060258, 14070259, 14070260, 14070261, 14070262, 14070263, 14070264, 14070265, 14070266, 14070267, 14070268, 14070269, 14070270, 14070271, 14070272, 14070273, 14070274, 14070275, 14070276, 14070277, 14070278, 14070279, 14070280, 14070281, 14070282, 14070283, 14070284, 14070285, 14070286, 14070287, 14070288, 14080289, 14080290, 14080291, 14080292, 14080293, 14080294, 14080295, 14080296, 14080297, 14080298, 14080299, 14080300, 14080301, 14080302, 14080303,. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2620-2024&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2620-2024&lang=eng" } }, "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." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2620-2024/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-2620-2024 as Class II", "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.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2620-2024&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2620-2024&lang=eng" } }, "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." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2620-2024/boundary", "@type": "schema:Claim", "name": "What an FDA recall is — and is NOT", "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.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "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." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-2620-2024", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-2620-2024", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "DKK Dai-Ichi Shomei Co., Ltd.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2024-07-09", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Model Number: AUT7-LH/TV-LH; Serial Numbers: 13040011, 13040012, 13040013, 13040014, 13040015, 13040016, 13040017, 13040018, 13040019, 13040020, 13040021, 13040022, 13040023, 13040024, 13070025, 13070026, 13070027, 13070028, 13070029, 13070030, 13070031, 13070032, 13070033, 13070034, 13070035, 13070036, 13070037, 13070038, 13070039, 13070040, 13070041, 13070042, 13070043, 13080044, 13080045, 13080046, 13080047, 13080048, 13080049, 13080050, 13080051, 13080052, 13080053, 13090054, 13090055, 13090056, 13090057, 13090058, 13090059, 13090060, 13090061, 13090062, 13090063, 13090064, 13090065, 13090066, 13090067, 13090068, 13090069, 13090070, 13090071, 13090072, 13090073, 13090074, 13090075, 13090076, 13090077, 13100078, 13100079, 13100080, 13100081, 13100082, 13100083, 13100084, 13100085, 13100086, 13100087, 13100088, 13100089, 13100090, 13100091, 13100092, 13100093, 13100094, 13100095, 13100096, 13100097, 13110098, 13110099, 13110100, 13110101, 13110102, 13110103, 13110104, 13110105, 13110106, 13110107, 13110108, 13110109, 13110110, 13110111, 13120112, 13120113, 13120114, 14010115, 14010116, 14010117, 14010118, 14010119, 14010120, 14010121, 14010122, 14010123, 14010124, 14010125, 14010126, 14010127, 14010128, 14010129, 14010130, 14010131, 14010132, 14010133, 14020134, 14020135, 14020136, 14020137, 14020138, 14020139, 14020140, 14020141, 14020142, 14020143, 14020144, 14020145, 14020146, 14020147, 14020148, 14020149, 14020150, 14020151, 14020152, 14020153, 14030154, 14030155, 14030156, 14030157, 14030158, 14030159, 14030160, 14030161, 14030162, 14030163, 14030164, 14030165, 14030166, 14030167, 14030168, 14030169, 14030170, 14030171, 14030172, 14030173, 14040174, 14040175, 14040176, 14040177, 14040178, 14040179, 14040180, 14040181, 14040182, 14040183, 14040184, 14040185, 14040186, 14040187, 14040188, 14040189, 14040190, 14040191, 14040192, 14040193, 14040194, 14040195, 14040196, 14040197, 14040198, 14040199, 14040200, 14040201, 14040202, 14040203, 14040204, 14040205, 14040206, 14040207, 14040208, 14040209, 14040210, 14040211, 14040212, 14040213, 14050214, 14050215, 14050216, 14050217, 14050218, 14050219, 14050220, 14050221, 14050222, 14050223, 14050224, 14050225, 14050226, 14050227, 14050228, 14050229, 14050230, 14050231, 14050232, 14050233, 14050234, 14050235, 14050236, 14050237, 14050238, 14050239, 14050240, 14050241, 14050242, 14050243, 14050244, 14050245, 14050246, 14050247, 14050248, 14050249, 14050250, 14050251, 14050252, 14050253, 14060254, 14060255, 14060256, 14060257, 14060258, 14070259, 14070260, 14070261, 14070262, 14070263, 14070264, 14070265, 14070266, 14070267, 14070268, 14070269, 14070270, 14070271, 14070272, 14070273, 14070274, 14070275, 14070276, 14070277, 14070278, 14070279, 14070280, 14070281, 14070282, 14070283, 14070284, 14070285, 14070286, 14070287, 14070288, 14080289, 14080290, 14080291, 14080292, 14080293, 14080294, 14080295, 14080296, 14080297, 14080298, 14080299, 14080300, 14080301, 14080302, 14080303,", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.", "Status": "recorded" } } ] } ] }