{ "@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-0465-2026.jsonld", "@type": "schema:Dataset", "name": "DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;", "description": "FDA recall Z-0465-2026 — Philips Medical Systems DMC GmbH is recalling DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035; (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-0465-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;", "manufacturer": { "@type": "schema:Organization", "name": "Philips Medical Systems DMC GmbH" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0465-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-0465-2026: Philips Medical Systems DMC GmbH is recalling DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;", "text": "The FDA logged enforcement record Z-0465-2026: Philips Medical Systems DMC GmbH is voluntarily recalling DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035; — reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-01. Affected lots/codes: 1. Model Number: 712034; UDI-DI: 00884838090699; Serial Numbers: 22860392, 22860404, 22860437, 22860556, 22860559, 22860578, 22860581, 22860583, 22860584, 23860409, 23860424, 23860428, 23860607, 23860625, 23860632, 23860652, 23860656, 23860658, 23860665, 23860667, 23860668, 23860669, 23860680, 23860684, 23860693, 23860700, 23860717, 23860769, 23860780, 23860812, 23860820, 23860823, 23860824, 24860041, 24860042, 24860043, 24861002, 24861010, 24861018, 24861020, 24861021, 24861031, 24861036, 24861039, 24861040, 24861041, 24861042, 24861055, 24861063, 24861072, 24861076, 24861083, 24861086, 24861088, 24861091, 24861105, 24861106, 24861107, 24861108, 24861110, 24861112, 24861114, 24861118, 24861121, 24861123, 24861124, 24861125, 24861126, 24861128, 24861130, 24861132, 24861133, 24861135, 24861136, 24861137, 24861138, 24861140, 24861141, 24861142, 24861143, 24861150, 24861153, 24861155, 24861160, 24861162, 24861165, 24861175, 24861203, 24861206, 24861207, 24861208, 24861216, 24861225, 24861226, 24861233, 24861234, 24861237, 24861238, 24861239, 24861240, 24861241, 24861242, 24861243, 24861245, 24861254, 24861255, 24861256, 24861257, 24861258, 24861259, 24861261, 24861262, 24861263, 24861264, 24861265, 24861268, 24861269, 24861271, 24861285, 24861286, 24861290, 24861291, 24861294, 24861295, 24861297, 24861298, 24861299, 24861300, 24861301, 24861305, 24861308, 24861314, 24861317, 24861318, 24861319, 24861320, 24861321, 24861324, 24861326, 24861327, 24861328, 24861329, 24861331, 24861340, 24861341, 24861342, 24861343, 24861344, 24861346, 24861352, 24861360, 24861361, 24861362, 24861363, 24861364, 24861365, 24861366, 24861367, 24861369, 24861370, 24861372, 24861373, 24861378, 24861381, 24861382, 24861385, 24861386, 24861387, 24861388, 24861389, 24861391, 24861397, 24861398, 24861399, 24861400, 24861401, 24861404, 24861405, 24861407, 24861408, 24861410, 24861411, 24861412, 24861413, 24861414, 24861418, 24861419, 24861420, 24861421, 24861423, 24861424, 24861428, 24861429, 24861435, 24861436, 24861438, 24861439, 24861440, 24861441, 24861442, 24861443, 24861446, 24861450, 24861451, 24861455, 24861456, 24861459, 24861460, 22860131; 2. Model Number: 712035; UDI-DI: 00884838090705; Serial Numbers: 23860438, 24861021, 24861023, 24861037, 24861044, 24861045, 24861046, 24861047, 24861054, 24861055, 24861061, 24861062, 24861063, 24861064;. 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-0465-2026&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-0465-2026&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-0465-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-0465-2026 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-0465-2026&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-0465-2026&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-0465-2026/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-0465-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-0465-2026", "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": "Philips Medical Systems DMC GmbH", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-10-01", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "1. Model Number: 712034; UDI-DI: 00884838090699; Serial Numbers: 22860392, 22860404, 22860437, 22860556, 22860559, 22860578, 22860581, 22860583, 22860584, 23860409, 23860424, 23860428, 23860607, 23860625, 23860632, 23860652, 23860656, 23860658, 23860665, 23860667, 23860668, 23860669, 23860680, 23860684, 23860693, 23860700, 23860717, 23860769, 23860780, 23860812, 23860820, 23860823, 23860824, 24860041, 24860042, 24860043, 24861002, 24861010, 24861018, 24861020, 24861021, 24861031, 24861036, 24861039, 24861040, 24861041, 24861042, 24861055, 24861063, 24861072, 24861076, 24861083, 24861086, 24861088, 24861091, 24861105, 24861106, 24861107, 24861108, 24861110, 24861112, 24861114, 24861118, 24861121, 24861123, 24861124, 24861125, 24861126, 24861128, 24861130, 24861132, 24861133, 24861135, 24861136, 24861137, 24861138, 24861140, 24861141, 24861142, 24861143, 24861150, 24861153, 24861155, 24861160, 24861162, 24861165, 24861175, 24861203, 24861206, 24861207, 24861208, 24861216, 24861225, 24861226, 24861233, 24861234, 24861237, 24861238, 24861239, 24861240, 24861241, 24861242, 24861243, 24861245, 24861254, 24861255, 24861256, 24861257, 24861258, 24861259, 24861261, 24861262, 24861263, 24861264, 24861265, 24861268, 24861269, 24861271, 24861285, 24861286, 24861290, 24861291, 24861294, 24861295, 24861297, 24861298, 24861299, 24861300, 24861301, 24861305, 24861308, 24861314, 24861317, 24861318, 24861319, 24861320, 24861321, 24861324, 24861326, 24861327, 24861328, 24861329, 24861331, 24861340, 24861341, 24861342, 24861343, 24861344, 24861346, 24861352, 24861360, 24861361, 24861362, 24861363, 24861364, 24861365, 24861366, 24861367, 24861369, 24861370, 24861372, 24861373, 24861378, 24861381, 24861382, 24861385, 24861386, 24861387, 24861388, 24861389, 24861391, 24861397, 24861398, 24861399, 24861400, 24861401, 24861404, 24861405, 24861407, 24861408, 24861410, 24861411, 24861412, 24861413, 24861414, 24861418, 24861419, 24861420, 24861421, 24861423, 24861424, 24861428, 24861429, 24861435, 24861436, 24861438, 24861439, 24861440, 24861441, 24861442, 24861443, 24861446, 24861450, 24861451, 24861455, 24861456, 24861459, 24861460, 22860131; 2. Model Number: 712035; UDI-DI: 00884838090705; Serial Numbers: 23860438, 24861021, 24861023, 24861037, 24861044, 24861045, 24861046, 24861047, 24861054, 24861055, 24861061, 24861062, 24861063, 24861064;", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,", "Status": "recorded" } } ] } ] }