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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1533-2025.jsonld",
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  "name": "Brand Name: AutoPulse NXT Resuscitation System  Product Name: AutoPulse NXT Platform  Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1)  Software Version: Version 2.0.1  Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR.  Component: N/A",
  "description": "FDA recall Z-1533-2025 — ZOLL Circulation, Inc. is recalling Brand Name: AutoPulse NXT Resuscitation System  Product Name: AutoPulse NXT Platform  Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1)  Software Version: Version 2.0.1  Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR.  Component: N/A (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.",
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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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1533-2025&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: AutoPulse NXT Resuscitation System  Product Name: AutoPulse NXT Platform  Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1)  Software Version: Version 2.0.1  Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR.  Component: N/A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "ZOLL Circulation, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1533-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1533-2025: ZOLL Circulation, Inc. is recalling Brand Name: AutoPulse NXT Resuscitation System  Product Name: AutoPulse NXT Platform  Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1)  Software Version: Version 2.0.1  Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR.  Component: N/A",
      "text": "The FDA logged enforcement record Z-1533-2025: ZOLL Circulation, Inc. is voluntarily recalling Brand Name: AutoPulse NXT Resuscitation System  Product Name: AutoPulse NXT Platform  Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1)  Software Version: Version 2.0.1  Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR.  Component: N/A — reason: AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-04. Affected lots/codes: UDI: (01) 00849111003384/Serial number: 1179 1168 1178 1184 1188 1197 1109 1110 1126 1166 1169 1152 1199 1202 1111 1185 1198 1203 1206 1208 1211 1212 1172 1182 1130 1128 1129 1189 1183 1131 1134 1191 1186 1192 1170 1173 1175 1180 1174 1176 1187 1177 1116 1165 1118 1119 1193 1138 1139 1145 1146 1147 1148 1149 1150 1153 1155 1159 1161 1162 1163 1164 1181 1141 1108 1190 1195 1120 1121 1122 1123    1107    1112    1113    1114    1115    1137   1140    1196. 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-1533-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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-1533-2025 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.",
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        "adjudged": true,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class I",
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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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1533-2025/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",
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      "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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            "Field": "Classification",
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            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "ZOLL Circulation, Inc.",
            "Status": "recorded"
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            "Value": "AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.",
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            "Field": "Initiated",
            "Value": "2025-03-04",
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            "Field": "Lot/code info",
            "Value": "UDI: (01) 00849111003384/Serial number: 1179 1168 1178 1184 1188 1197 1109 1110 1126 1166 1169 1152 1199 1202 1111 1185 1198 1203 1206 1208 1211 1212 1172 1182 1130 1128 1129 1189 1183 1131 1134 1191 1186 1192 1170 1173 1175 1180 1174 1176 1187 1177 1116 1165 1118 1119 1193 1138 1139 1145 1146 1147 1148 1149 1150 1153 1155 1159 1161 1162 1163 1164 1181 1141 1108 1190 1195 1120 1121 1122 1123    1107    1112    1113    1114    1115    1137   1140    1196",
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            "Field": "Distribution pattern",
            "Value": "US: AL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK< PA, TX, WI OUS: Canada, Hong Kong,",
            "Status": "recorded"
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