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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2324-2024.jsonld",
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  "name": "ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA).     Model/Catalog Number:    G5S-00A  G5S-00A-TSO  G5S-00C  G5S-01A  G5S-02A  G5S-02C  G5S-02-L  G5S-04A  G5S-05A  G5S-05C  G5S-06A  G5S-06C  G5S-08A  G5S-08C  G5S-10A  G5S-10C  G5S-11A  G5S-11C  G5S-12C  G5S-13A  G5S-14A  G5S-15A  G5S-17A  G5S-17C  G5S-19A  G5S-23C  G5S-29A  G5S-29C  G5S-31A  G5S-31A-SJA  G5S-31C-SJA  G5S-36A  G5S-37A  G5S-41A  G5S-41C  G5S-80A  G5S-80A-TSO  G5S-80C  G5S-80-L  G5S-82A  G5S-82C  G5S-83C  G5S-90C",
  "description": "FDA recall Z-2324-2024 — Zoll Medical Corporation is recalling ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA).     Model/Catalog Number:    G5S-00A  G5S-00A-TSO  G5S-00C  G5S-01A  G5S-02A  G5S-02C  G5S-02-L  G5S-04A  G5S-05A  G5S-05C  G5S-06A  G5S-06C  G5S-08A  G5S-08C  G5S-10A  G5S-10C  G5S-11A  G5S-11C  G5S-12C  G5S-13A  G5S-14A  G5S-15A  G5S-17A  G5S-17C  G5S-19A  G5S-23C  G5S-29A  G5S-29C  G5S-31A  G5S-31A-SJA  G5S-31C-SJA  G5S-36A  G5S-37A  G5S-41A  G5S-41C  G5S-80A  G5S-80A-TSO  G5S-80C  G5S-80-L  G5S-82A  G5S-82C  G5S-83C  G5S-90C (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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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA).     Model/Catalog Number:    G5S-00A  G5S-00A-TSO  G5S-00C  G5S-01A  G5S-02A  G5S-02C  G5S-02-L  G5S-04A  G5S-05A  G5S-05C  G5S-06A  G5S-06C  G5S-08A  G5S-08C  G5S-10A  G5S-10C  G5S-11A  G5S-11C  G5S-12C  G5S-13A  G5S-14A  G5S-15A  G5S-17A  G5S-17C  G5S-19A  G5S-23C  G5S-29A  G5S-29C  G5S-31A  G5S-31A-SJA  G5S-31C-SJA  G5S-36A  G5S-37A  G5S-41A  G5S-41C  G5S-80A  G5S-80A-TSO  G5S-80C  G5S-80-L  G5S-82A  G5S-82C  G5S-83C  G5S-90C",
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      "name": "Zoll Medical Corporation"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2324-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2324-2024: Zoll Medical Corporation is recalling ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA).     Model/Catalog Number:    G5S-00A  G5S-00A-TSO  G5S-00C  G5S-01A  G5S-02A  G5S-02C  G5S-02-L  G5S-04A  G5S-05A  G5S-05C  G5S-06A  G5S-06C  G5S-08A  G5S-08C  G5S-10A  G5S-10C  G5S-11A  G5S-11C  G5S-12C  G5S-13A  G5S-14A  G5S-15A  G5S-17A  G5S-17C  G5S-19A  G5S-23C  G5S-29A  G5S-29C  G5S-31A  G5S-31A-SJA  G5S-31C-SJA  G5S-36A  G5S-37A  G5S-41A  G5S-41C  G5S-80A  G5S-80A-TSO  G5S-80C  G5S-80-L  G5S-82A  G5S-82C  G5S-83C  G5S-90C",
      "text": "The FDA logged enforcement record Z-2324-2024: Zoll Medical Corporation is voluntarily recalling ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA).     Model/Catalog Number:    G5S-00A  G5S-00A-TSO  G5S-00C  G5S-01A  G5S-02A  G5S-02C  G5S-02-L  G5S-04A  G5S-05A  G5S-05C  G5S-06A  G5S-06C  G5S-08A  G5S-08C  G5S-10A  G5S-10C  G5S-11A  G5S-11C  G5S-12C  G5S-13A  G5S-14A  G5S-15A  G5S-17A  G5S-17C  G5S-19A  G5S-23C  G5S-29A  G5S-29C  G5S-31A  G5S-31A-SJA  G5S-31C-SJA  G5S-36A  G5S-37A  G5S-41A  G5S-41C  G5S-80A  G5S-80A-TSO  G5S-80C  G5S-80-L  G5S-82A  G5S-82C  G5S-83C  G5S-90C — reason: G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and  shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-31. Affected lots/codes: GTIN: 00812394021239 00812394021277 00812394021284 00812394021413 00812394022779 00847946038182 00847946038199 00847946038243 00847946038250 00847946038304 00847946038328 00847946038335 00847946038342 00847946038359 00847946038380 00847946038397 00847946038403 00847946038410 00847946038434 00847946038441 00847946038496 00847946038519 00847946038533 00847946038571 00847946038588 00847946038663 00847946038816 00847946038830 00847946039028 00847946039035 00847946039066 00847946039127     Serial Number Range: D00000276194-D00000343449. 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-2324-2024&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-2324-2024&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-2324-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2324-2024 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.",
      "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-2324-2024&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-2324-2024&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-2324-2024/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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
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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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-2324-2024",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2324-2024",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
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          "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": "Zoll Medical Corporation",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and  shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-31",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN: 00812394021239 00812394021277 00812394021284 00812394021413 00812394022779 00847946038182 00847946038199 00847946038243 00847946038250 00847946038304 00847946038328 00847946038335 00847946038342 00847946038359 00847946038380 00847946038397 00847946038403 00847946038410 00847946038434 00847946038441 00847946038496 00847946038519 00847946038533 00847946038571 00847946038588 00847946038663 00847946038816 00847946038830 00847946039028 00847946039035 00847946039066 00847946039127     Serial Number Range: D00000276194-D00000343449",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide including PR. Foreign: AU BM CA CH DE DK ES FR GB HK HU ID IE IL IT KR MA MT NL NO PR SA SE SI SN TR",
            "Status": "recorded"
          }
        }
      ]
    }
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}