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  "name": "Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device  Model Number (REF):   (1) 781283;  (2) 781346",
  "description": "FDA recall Z-1837-2024 — Philips North America Llc is recalling Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device  Model Number (REF):   (1) 781283;  (2) 781346 (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": "Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device  Model Number (REF):   (1) 781283;  (2) 781346",
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      "name": "Philips North America Llc"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1837-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1837-2024: Philips North America Llc is recalling Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device  Model Number (REF):   (1) 781283;  (2) 781346",
      "text": "The FDA logged enforcement record Z-1837-2024: Philips North America Llc is voluntarily recalling Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device  Model Number (REF):   (1) 781283;  (2) 781346 — reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's  technical room, resulting in Smoke and/or fire. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-03. Affected lots/codes: UDI-DI:  1. (01)00884838068469(21) 2. (01)00884838009806(21)  (1) Serial Numbers: 39011 39056 39084 39102 8989 10126 39098 39022 39079 39026 39097 39108 39082 39006 39013 39041 39081 39092 39096 39100 39010 39028 39032 39066 39086 39094 39095 39107 39001 39004 39064 39074 39007 39012 39029 39030 39034 39036 39038 39039 39040 39042 39054 39057 39058 39059 39062 39071 39075 39077 39080 39083 39088 39089 39091 39099 39105 39093 39053 39023 39008 39072 39073 39090 39104 39065 39052 39067 39085 39016 39025 39027 39060  (2) 18052 8361 8415 10015 75008 5243 8727 10172 10189 10545 18737 75002 75003 75004 75015 5547 8059 8767 8842 8883 8886 8897 8946 8981 8990 10060 18001 18710 75009 75092 75095 75099 75100 8276 10194 10512 8069 8312 8520 10006 10048 18588 75000 75001 75005 75049 75087 8289 8367 8714 8740 10539 75011 8351 8398 8782 75068 8756 75010 18505 75007 8371 8124 8467 8020 10219. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
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        "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-1837-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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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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      "name": "FDA classified recall Z-1837-2024 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.",
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        "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-1837-2024&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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1837-2024/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.",
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        "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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            "Value": "Devices",
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            "Value": "Class II",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
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            "Status": "recorded"
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            "Field": "Reason",
            "Value": "The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's  technical room, resulting in Smoke and/or fire",
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            "Value": "2024-05-03",
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            "Value": "UDI-DI:  1. (01)00884838068469(21) 2. (01)00884838009806(21)  (1) Serial Numbers: 39011 39056 39084 39102 8989 10126 39098 39022 39079 39026 39097 39108 39082 39006 39013 39041 39081 39092 39096 39100 39010 39028 39032 39066 39086 39094 39095 39107 39001 39004 39064 39074 39007 39012 39029 39030 39034 39036 39038 39039 39040 39042 39054 39057 39058 39059 39062 39071 39075 39077 39080 39083 39088 39089 39091 39099 39105 39093 39053 39023 39008 39072 39073 39090 39104 39065 39052 39067 39085 39016 39025 39027 39060  (2) 18052 8361 8415 10015 75008 5243 8727 10172 10189 10545 18737 75002 75003 75004 75015 5547 8059 8767 8842 8883 8886 8897 8946 8981 8990 10060 18001 18710 75009 75092 75095 75099 75100 8276 10194 10512 8069 8312 8520 10006 10048 18588 75000 75001 75005 75049 75087 8289 8367 8714 8740 10539 75011 8351 8398 8782 75068 8756 75010 18505 75007 8371 8124 8467 8020 10219",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada,  China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan,  Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia,  Spain, Sweden, Switzerland, Thailand, United Kingdom.",
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