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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2660-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "MAGNETOM Skyra (DE). Model Number: 10432915.    510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.",
  "description": "FDA recall Z-2660-2025 — Siemens Medical Solutions USA, Inc is recalling MAGNETOM Skyra (DE). Model Number: 10432915.    510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560. (Devices, Class I). 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/",
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  "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": {
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      "name": "U.S. Food & Drug Administration"
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MAGNETOM Skyra (DE). Model Number: 10432915.    510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.",
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      "name": "Siemens Medical Solutions USA, Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2660-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2660-2025: Siemens Medical Solutions USA, Inc is recalling MAGNETOM Skyra (DE). Model Number: 10432915.    510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.",
      "text": "The FDA logged enforcement record Z-2660-2025: Siemens Medical Solutions USA, Inc is voluntarily recalling MAGNETOM Skyra (DE). Model Number: 10432915.    510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560. — reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-28. Affected lots/codes: Model Number: 10432915. 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Additional serial numbers added 11/14/2025: 45395, 45442, 45291.  Additional serial numbers added 01/23/2026: 45108, 45129. Additional serial numbers added 2/25/2026: 45635, 46150, 145696, 46220, 45425, 45733, 45186, 46268, 45913.. 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-2660-2025&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-2660-2025&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-2660-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2660-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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-2660-2025&lang=eng",
        "value": "Class I",
        "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-2660-2025&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-2660-2025/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."
    }
  ],
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      "name": "FDA recall details — Z-2660-2025",
      "numberOfItems": 9,
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            "Field": "Recall number",
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            "Status": "recorded"
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        },
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
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        {
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          "position": 3,
          "item": {
            "Field": "Classification",
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          "position": 4,
          "item": {
            "Field": "Status",
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Siemens Medical Solutions USA, Inc",
            "Status": "recorded"
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        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.",
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          }
        },
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          "item": {
            "Field": "Initiated",
            "Value": "2025-08-28",
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        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model Number: 10432915. 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Serial Numbers: 45046, 45115, 45398, 145760, 145811, 45549, 45834, 146099, 146110, 45047, 146093, 46066, 45788, 146082, 45124, 45185, 45332, 45466, 145390, 45732, 45918, 45380, 46182, 45735, 45233, 145735, 145008, 145473, 145095, 145664, 45200, 146098, 146086, 45805, 45812, 45397, 46264, 45499, 45749, 45289, 46220, 45369, 45267, 45253, 45060, 146103, 45333, 146123, 46147, 145721, 145840, 145088, 146124, 45841, 45890, 46295, 45306, 45519, 145905, 46242, 145806, 46171, 45148, 45152, 46194, 145152, 45119, 46207, 145549, 45402, 145090, 145681, 45877, 45693, 45679, 146067, 45140, 46163, 145635, 46028, 45138, 46282, 45479, 45496, 45143, 45314, 45368, 46268, 45998, 145423, 145190, 145377, 46005, 45886, 45905, 145706, 145684, 45990, 145063, 146119, 46260, 45118, 145062, 45506, 145528, 145547, 46206, 145552, 45129, 145330, 45910, 145128, 145750, 45976, 145688, 45182, 145497, 45411, 145150, 45213, 145115, 45683, 145672, 145526, 45737, 45753, 145041, 145042, 45339, 45338, 145040, 145167, 45403, 145799, 145843, 145658, 145086, 45197, 45196, 145108, 46203, 145414, 46027, 145301, 45988, 45279, 145384, 145596, 45881, 145568, 45942, 146085, 145685, 145674, 45088, 145862, 45095, 45676, 46144, 45108, 145300, 46044, 46169, 45537, 145026, 46290, 145758, 45084, 145270, 146117, 146092, 45195, 145631, 45684, 45940, 146114, 145666, 145380, 145816, 45120, 145921, 145842, 145554, 46232, 45135, 145710, 145044, 145686, 46279, 145638, 145367, 145170, 145689, 145187, 45495, 45298, 145164, 46176, 45399, 46261, 145334, 145633, 45375, 45351, 146128, 45276, 46179, 145610, 46048, 145810, 46168, 46121, 45705, 45284, 145669, 145831, 145206, 145667, 45477, 145104, 45112, 146075, 145445, 46032, 145544, 46050, 45212, 46276, 145687, 145099, 145256, 46161, 46020, 45761, 145338, 45736, 145541, 145545, 145259, 145952, 46149, 45149, 45407, 45327, 45944, 45006, 45371, 46238, 145130, 45983, 46189, 145700, 45236, 45201, 145747, 46273, 45520, 145774, 46303, 45116, 145262, 145663, 45456, 45624, 145754, 45599, 145148, 45690, 45963, 45346, 45995, 45293, 145179, 45770, 145161, 145145, 145620, 145476, 46127, 45435, 45155, 46047, 45295, 45160, 45603, 145892, 45543, 45847, 145269, 145770, 46259, 45817, 145827, 45856, 45526, 145731, 145640, 145266, 45117, 45324, 45968, 145775, 45372, 145454, 45249, 45958, 145343, 145255, 145110, 46286, 145609, 145790, 145030, 145011, 145012, 145105, 45219, 145061, 145533, 145532, 45774, 45167, 45069, 146105, 145924, 145113, 45085, 45741, 45147, 145193, 46289, 145622, 45121, 45150, 46175, 45536, 46237, 145032, 46191, 46143, 45733, 46081, 45158, 45110, 145492, 46100, 45379, 45318, 145394, 45681, 145886, 145491, 45425, 145761, 45031, 145632, 145182, 145124, 45996, 45107, 45428, 45635, 46021, 46007, 46105, 46142, 45203, 45018, 145850, 146102, 146100, 45019, 145826, 145521, 145860, 45417, 45928, 145097, 145323, 46205, 145325, 45906, 146115, 45815, 45042, 145594, 145801, 45500, 45986, 45202, 45553, 45381, 145020, 45566, 145990, 145728, 45959, 46009, 45134, 145447, 45474, 145149, 45099, 45349, 46150, 145143, 46016, 145605, 146127, 145785, 45623, 145089, 145209, 45835, 145302, 145815, 45082, 45079, 45878, 45452, 145246, 46086, 45850, 46239, 46140, 45773, 145293, 145127, 45556, 45870, 145486, 46026, 145485, 145403, 145624, 145245, 46034, 45455, 145443, 145297, 45288, 145582, 145772, 46297, 45667, 45430, 146090, 45074, 45585, 45128, 45239, 145386, 145489, 45328, 45580, 45122, 45078, 145449, 45387, 45804, 145536, 145569, 145781, 145629, 145504, 45682, 45072, 145565, 46222, 45948, 145718, 145282, 45056, 45970, 45408, 145066, 145796, 46310, 46311, 45273, 45214, 45631, 45386, 145275, 145704, 45406, 46107, 46102, 45080, 145717, 145320, 45220, 45424, 145522, 145230, 45228, 45348, 45649, 46190, 145142, 145636, 145222, 145111, 145598, 45181, 45229, 45105, 145839, 45840, 45685, 145292, 45132, 46288, 45291, 45857, 46157, 45266, 45839, 45208, 146078, 145450, 45307, 45982, 46145, 46298, 145169, 45237, 45869, 45230, 45205, 45694, 45507, 46281, 145311, 45232, 145662, 45390, 145087, 45255, 145332, 45409, 45559, 45130, 146120, 145197, 45777, 145072, 145626, 145794, 145864, 146122, 146121, 45669, 45801, 45436, 45545, 46201, 46080, 45945, 145227, 45093, 46243, 45818, 45071, 45111, 145075, 46294, 45199, 45638. Additional serial numbers added 11/14/2025: 45395, 45442, 45291.  Additional serial numbers added 01/23/2026: 45108, 45129. Additional serial numbers added 2/25/2026: 45635, 46150, 145696, 46220, 45425, 45733, 45186, 46268, 45913.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}