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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0972-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "NovoTHOR Whole Body Light Pod, Gen 3.0    (1) Product Code S2188 - Reg  (2) Product Code S2189 - Reg PRX  (3) Product Code S2190 - XL",
  "description": "FDA recall Z-0972-2024 — THOR Photomedicine Ltd is recalling NovoTHOR Whole Body Light Pod, Gen 3.0    (1) Product Code S2188 - Reg  (2) Product Code S2189 - Reg PRX  (3) Product Code S2190 - XL (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0972-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "NovoTHOR Whole Body Light Pod, Gen 3.0    (1) Product Code S2188 - Reg  (2) Product Code S2189 - Reg PRX  (3) Product Code S2190 - XL",
    "manufacturer": {
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      "name": "THOR Photomedicine Ltd"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0972-2024/enforcement-record",
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      "name": "FDA recall Z-0972-2024: THOR Photomedicine Ltd is recalling NovoTHOR Whole Body Light Pod, Gen 3.0    (1) Product Code S2188 - Reg  (2) Product Code S2189 - Reg PRX  (3) Product Code S2190 - XL",
      "text": "The FDA logged enforcement record Z-0972-2024: THOR Photomedicine Ltd is voluntarily recalling NovoTHOR Whole Body Light Pod, Gen 3.0    (1) Product Code S2188 - Reg  (2) Product Code S2189 - Reg PRX  (3) Product Code S2190 - XL — reason: One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-20. Affected lots/codes: (1) UDI-DI 05060494130503 Serial Numbers  4004 4009 4013 4017 4019 4021 4024 4026 4028 4029 4035 4037 4042 4043 4044 4046 4047 4048 4054 4065 4066 4072 4073 4074 4076 4077 4078 4079 4080 4081 4082 4083 4085 4086 4087 4090 4091 4096  (2) UDI-DI 05060494130527 Serial Number 4068  (3) UDI-DI 05060494130510 Serial Numbers 4002 4003 4006 4010 4012 4027 4030 4040 4038 4023 4045 4051 4052 4060 4057 4064 4056 4069 4063 4070 4089 4014. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": 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-0972-2024&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-0972-2024&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-0972-2024/fda-classification",
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      "name": "FDA classified recall Z-0972-2024 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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        "adjudged": true,
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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-0972-2024&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-0972-2024/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": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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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      "name": "FDA recall details — Z-0972-2024",
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            "Value": "Z-0972-2024",
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            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "THOR Photomedicine Ltd",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-11-20",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "(1) UDI-DI 05060494130503 Serial Numbers  4004 4009 4013 4017 4019 4021 4024 4026 4028 4029 4035 4037 4042 4043 4044 4046 4047 4048 4054 4065 4066 4072 4073 4074 4076 4077 4078 4079 4080 4081 4082 4083 4085 4086 4087 4090 4091 4096  (2) UDI-DI 05060494130527 Serial Number 4068  (3) UDI-DI 05060494130510 Serial Numbers 4002 4003 4006 4010 4012 4027 4030 4040 4038 4023 4045 4051 4052 4060 4057 4064 4056 4069 4063 4070 4089 4014",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Domestic distribution to the states of Arizona California Colorado Connecticut Florida Georgia Hawaii Idaho Indiana Maryland New Jersey New York Oregon Pennsylvania Texas Washington Wisconsin.  Foreign distribution to Australia, Canada, Italy, Malta, Norway, Switzerland, UAE, and UK.",
            "Status": "recorded"
          }
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}