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  "name": "SIGNA Architect, Nuclear Magnetic Resonance Imaging System",
  "description": "FDA recall Z-0518-2025 — GE Medical Systems, LLC is recalling SIGNA Architect, Nuclear Magnetic Resonance Imaging System (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "SIGNA Architect, Nuclear Magnetic Resonance Imaging System",
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      "name": "GE Medical Systems, LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0518-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0518-2025: GE Medical Systems, LLC is recalling SIGNA Architect, Nuclear Magnetic Resonance Imaging System",
      "text": "The FDA logged enforcement record Z-0518-2025: GE Medical Systems, LLC is voluntarily recalling SIGNA Architect, Nuclear Magnetic Resonance Imaging System — reason: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-28. Affected lots/codes: UDI/DI  (01)00840682147095(11)240100(21)PG75M2400278SC, System ID 303467MR2;  UDI/DI  To be provided, System ID 1000005000;  UDI/DI  (01)00840682147095(11)220800(21)PG75M2300225SC, System ID 217528MR4;  UDI/DI  (01)00840682147095(11)220600(21)PG75M2200130SC, System ID 781SSHMR3;  UDI/DI  To be provided, System ID 301295AMR2;  UDI/DI  To be provided, System ID GON90303794;  UDI/DI  To be provided, System ID 215955HON3T;  UDI/DI  (01)00840682147095(11)230600(21)PG75M2300245SC, System ID 806UMCHWMR3T;  UDI/DI  (01)00840682147095(11)230800(21)PG75M2300255SC, System ID 703573ARC7;  UDI/DI  (01)00840682122702(11)220100(21)PG75A2300133SC, System ID 757953SPMR;  UDI/DI  (01)00840682147095(11)231000(21)PG75M2300263SC, System ID 905684MR3T;  UDI/DI  (01)00840682147095(11)220800(21)PG75M2200153SC, System ID 82427160355;  UDI/DI  To be provided, System ID 82427100482;  UDI/DI  To be provided, System ID 82427140330;  UDI/DI  To be provided, System ID 82427040333;  UDI/DI  To be provided, System ID 82427200209;  UDI/DI  To be provided, System ID 82427050061;  UDI/DI  To be provided, System ID 82427080138;  UDI/DI  (01)00840682147095(11)230400(21)PG75M2300232SC, System ID 82427150128;  UDI/DI  To be provided, System ID 82427200219;  UDI/DI  To be provided, System ID 82427080142;  UDI/DI  To be provided, System ID 82427230234;  UDI/DI  (01)00840682147095(11)231000(21)PG75M2300266SC, System ID 82427100499;  UDI/DI  To be provided, System ID 82427160405;  UDI/DI  To be provided, System ID 82427160407;  UDI/DI  (01)00840682147095(11)230600(21)PG75M2300247SC, System ID 82427160390;  UDI/DI  To be provided, System ID 82427160408;  UDI/DI  To be provided, System ID 82427160402;  UDI/DI  To be provided, System ID 82427120372;  UDI/DI  To be provided, System ID 82427120357;  UDI/DI  To be provided, System ID 82427120351;  UDI/DI  (01)00840682147095(11)230700(21)PG75M2300253SC, System ID 82427150130;  UDI/DI  (01)00840682147095(11)240100(21)PG75M2400276SC, System ID 82427030222;  UDI/DI  (01)00195278283481(11)231113(21)CNARC2300071TJ, System ID 82427030218;  UDI/DI  (01)00840682147095(11)230600(21)PG75M2300248SC, System ID 83027009451123;  UDI/DI  (01)00840682147095(11)240200(21)ANTAT2400005TJ, System ID MR00169;  UDI/DI  (01)00840682147095(11)240200(21)ANTAT2400004TJ, System ID MR00168;  UDI/DI  (01)00840682147095(11)240100(21)ANTAT2400001TJ, System ID MR00185;  UDI/DI  (01)00840682122702(11)180223(21)PG75A1800019MR, System ID 850270540;  UDI/DI  To be provided, System ID 850270791;  UDI/DI  To be provided, System ID LV4001MR03;  UDI/DI  (01)00840682147095(11)230600(21)PG75M2300246SC, System ID MRUA2408;  UDI/DI  To be provided, System ID P00434MR01;  UDI/DI  To be provided, System ID RF3138MR01;  UDI/DI  To be provided, System ID RU1838MR04;  UDI/DI  To be provided, System ID RF3580MR01;  UDI/DI  To be provided, System ID SA1058MR05;  UDI/DI  (01)00840682147095(11)221100(21)PG75M2200180SC, System ID FEG88320;  UDI/DI  (01)00840682147095(11)230800(21)PG75M2300256SC, System ID DE492A99;  UDI/DI  To be provided, System ID NEV439249;  UDI/DI  To be provided, System ID 853270212;  UDI/DI  To be provided, System ID 853270202;  UDI/DI  (01)00840682147095(11)230300(21)PG75M2300227SC, System ID 853270223. A RECORDED FDA enforcement action (occurred=true).",
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      "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0518-2025/fda-classification",
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      "name": "FDA classified recall Z-0518-2025 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.",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
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      "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-0518-2025/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.",
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      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": false,
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      "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-0518-2025",
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            "Value": "Z-0518-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "GE Medical Systems, LLC",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-10-28",
            "Status": "recorded"
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            "Value": "UDI/DI  (01)00840682147095(11)240100(21)PG75M2400278SC, System ID 303467MR2;  UDI/DI  To be provided, System ID 1000005000;  UDI/DI  (01)00840682147095(11)220800(21)PG75M2300225SC, System ID 217528MR4;  UDI/DI  (01)00840682147095(11)220600(21)PG75M2200130SC, System ID 781SSHMR3;  UDI/DI  To be provided, System ID 301295AMR2;  UDI/DI  To be provided, System ID GON90303794;  UDI/DI  To be provided, System ID 215955HON3T;  UDI/DI  (01)00840682147095(11)230600(21)PG75M2300245SC, System ID 806UMCHWMR3T;  UDI/DI  (01)00840682147095(11)230800(21)PG75M2300255SC, System ID 703573ARC7;  UDI/DI  (01)00840682122702(11)220100(21)PG75A2300133SC, System ID 757953SPMR;  UDI/DI  (01)00840682147095(11)231000(21)PG75M2300263SC, System ID 905684MR3T;  UDI/DI  (01)00840682147095(11)220800(21)PG75M2200153SC, System ID 82427160355;  UDI/DI  To be provided, System ID 82427100482;  UDI/DI  To be provided, System ID 82427140330;  UDI/DI  To be provided, System ID 82427040333;  UDI/DI  To be provided, System ID 82427200209;  UDI/DI  To be provided, System ID 82427050061;  UDI/DI  To be provided, System ID 82427080138;  UDI/DI  (01)00840682147095(11)230400(21)PG75M2300232SC, System ID 82427150128;  UDI/DI  To be provided, System ID 82427200219;  UDI/DI  To be provided, System ID 82427080142;  UDI/DI  To be provided, System ID 82427230234;  UDI/DI  (01)00840682147095(11)231000(21)PG75M2300266SC, System ID 82427100499;  UDI/DI  To be provided, System ID 82427160405;  UDI/DI  To be provided, System ID 82427160407;  UDI/DI  (01)00840682147095(11)230600(21)PG75M2300247SC, System ID 82427160390;  UDI/DI  To be provided, System ID 82427160408;  UDI/DI  To be provided, System ID 82427160402;  UDI/DI  To be provided, System ID 82427120372;  UDI/DI  To be provided, System ID 82427120357;  UDI/DI  To be provided, System ID 82427120351;  UDI/DI  (01)00840682147095(11)230700(21)PG75M2300253SC, System ID 82427150130;  UDI/DI  (01)00840682147095(11)240100(21)PG75M2400276SC, System ID 82427030222;  UDI/DI  (01)00195278283481(11)231113(21)CNARC2300071TJ, System ID 82427030218;  UDI/DI  (01)00840682147095(11)230600(21)PG75M2300248SC, System ID 83027009451123;  UDI/DI  (01)00840682147095(11)240200(21)ANTAT2400005TJ, System ID MR00169;  UDI/DI  (01)00840682147095(11)240200(21)ANTAT2400004TJ, System ID MR00168;  UDI/DI  (01)00840682147095(11)240100(21)ANTAT2400001TJ, System ID MR00185;  UDI/DI  (01)00840682122702(11)180223(21)PG75A1800019MR, System ID 850270540;  UDI/DI  To be provided, System ID 850270791;  UDI/DI  To be provided, System ID LV4001MR03;  UDI/DI  (01)00840682147095(11)230600(21)PG75M2300246SC, System ID MRUA2408;  UDI/DI  To be provided, System ID P00434MR01;  UDI/DI  To be provided, System ID RF3138MR01;  UDI/DI  To be provided, System ID RU1838MR04;  UDI/DI  To be provided, System ID RF3580MR01;  UDI/DI  To be provided, System ID SA1058MR05;  UDI/DI  (01)00840682147095(11)221100(21)PG75M2200180SC, System ID FEG88320;  UDI/DI  (01)00840682147095(11)230800(21)PG75M2300256SC, System ID DE492A99;  UDI/DI  To be provided, System ID NEV439249;  UDI/DI  To be provided, System ID 853270212;  UDI/DI  To be provided, System ID 853270202;  UDI/DI  (01)00840682147095(11)230300(21)PG75M2300227SC, System ID 853270223",
            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.",
            "Status": "recorded"
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