{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2143-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "HeartSine, REF:  PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and  with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P",
  "description": "FDA recall Z-2143-2023 — HeartSine Technologies Ltd is recalling HeartSine, REF:  PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and  with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "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-2143-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "HeartSine, REF:  PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and  with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "HeartSine Technologies Ltd"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2143-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2143-2023: HeartSine Technologies Ltd is recalling HeartSine, REF:  PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and  with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P",
      "text": "The FDA logged enforcement record Z-2143-2023: HeartSine Technologies Ltd is voluntarily recalling HeartSine, REF:  PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and  with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P — reason: Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-04-26. Affected lots/codes: Model #/UDI-DI #: 360-BAS-UK-10/05060167122606, 350-BAS-UK-10/05060167121418, 350-BAS-AS-10/05060167121371, 350-BAS-CF-10/05060167124747, 350-BAS-CN-10/05060167121593, 350-BAS-JA-08/05060167124525, 350-BAS-KO-10/05060167121517, 350-BAS-MS-10/05060167120800, 350-BAS-USROW-10/05060167121630, 360-BAS-AS-10/05060167122514, 360-BAS-CN-10/05060167125751, 360-BAS-KO-10/05060167122712, 360-BAS-SJ-10/05060167128028, 450-BAS-JA-08/05060167127663, 500-BAS-AS-10/05060167125812, 500-BAS-CF-10/05060167125836, 500-BAS-CN-10/05060167125843, 500-BAS-KO-10/05060167126444, 500-BAS-TH-10/05060167125997, 500-BAS-UK-10/05060167122453, PAD-PAK-01/05060167120466,PAD-PAK-03/05060167121234,PAD-PAK-03j/05060167124754   Models/Lot #   360-BAS-UK-10/ A3659, A3655, A3664, A3654, A3803, A3829, A3840, A3842, A3848,  A3840, A3843, A3842, A3844, A3842, J0754, J0754, J0755,  J0752, J0798;  350-BAS-UK-10/ A3664, A3799, A3803, A3829,A3840,A3846, J0753, J0753, J0754, J0756;  350-BAS-AS-10/ A3656; 350-BAS-CF-10/ A3635, A3805, J0801;  350-BAS-CN-10/ A3633, A3636, A3805, A3833, J0801; 350-BAS-JA-08/ A3779  A3783, A3780, A3783, J0758, J0758;  350-BAS-KO-10/ J0753;  350-BAS-MS-10/ J0753; 350-BAS-USROW-10/ A3644; 360-BAS-AS-10/ A3656; 360-BAS-CN-10/ A3635; 360-BAS-KO-10/A3660 A3646, A3665, J0753, J0754;  360-BAS-SJ-10/ A3660; 450-BAS-JA-08/ A3779, A3783, A3788, A3821; 500-BAS-AS-10/ A3656; 500-BAS-CF-10/ A3635; 500-BAS-CN-10/ A3632, A3635, A3634, A3681; 500-BAS-KO-10/ A3660; 500-BAS-TH-10/ J0754, J0755, J0754; 500-BAS-UK-10/ A3654, A3654, A3664, A3664, A3765, A3787, A3801, A3840, J0753, J0755, J0754, J0756, J0748, J0798;   PAD-PAK-01/ A3632 A3633 A3634 A3635 A3636 A3637 A3642 A3656  A3657 A3657 A3657  A3662 A3669 A3681 A3678 A3682 A3766, A3777 A3778 A3781 A3782 A3805 A3807 A3833 A3833 A3834 A3834  A3832 A3840 J0759 J0761  J0760;  PAD-PAK-03/ A3638  A3639 A3640  A3658  A3644  A3644 A3655  A3666  A3653 A3652 A3641  A3643  A3660  A3664  A3665  A3672 A3663 A3668 A3667 A3661 A3659  A3764 A3765 A3770  A3772  A3773  A3774 A3775 A3776 A3779  A3784  A3785  A3786 A3787  A3787 A3785  A3799  A3799 A3800  A3801  A3802 A3802  A3803 A3804  A3829 A3829  A3840  A3845  A3846  A3847  A3849  A3849 A3845 J0749  J0749 J0748  J0750  J0751  J0752  J0753 J0753  J0754  J0756  J0786  J0786  J0790  J0791  J0787 J0788  J0788  J0789 J0792 J0792  J0795 J0794 J0793 J0792  J0796  J0797  J0798  J0799;  PAD-PAK-03j/ A3788 and A3821. 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-2143-2023&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-2143-2023&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-2143-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2143-2023 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-2143-2023&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-2143-2023&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-2143-2023/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
      },
      "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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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2143-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2143-2023",
            "Status": "recorded"
          }
        },
        {
          "@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": "HeartSine Technologies Ltd",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-04-26",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model #/UDI-DI #: 360-BAS-UK-10/05060167122606, 350-BAS-UK-10/05060167121418, 350-BAS-AS-10/05060167121371, 350-BAS-CF-10/05060167124747, 350-BAS-CN-10/05060167121593, 350-BAS-JA-08/05060167124525, 350-BAS-KO-10/05060167121517, 350-BAS-MS-10/05060167120800, 350-BAS-USROW-10/05060167121630, 360-BAS-AS-10/05060167122514, 360-BAS-CN-10/05060167125751, 360-BAS-KO-10/05060167122712, 360-BAS-SJ-10/05060167128028, 450-BAS-JA-08/05060167127663, 500-BAS-AS-10/05060167125812, 500-BAS-CF-10/05060167125836, 500-BAS-CN-10/05060167125843, 500-BAS-KO-10/05060167126444, 500-BAS-TH-10/05060167125997, 500-BAS-UK-10/05060167122453, PAD-PAK-01/05060167120466,PAD-PAK-03/05060167121234,PAD-PAK-03j/05060167124754   Models/Lot #   360-BAS-UK-10/ A3659, A3655, A3664, A3654, A3803, A3829, A3840, A3842, A3848,  A3840, A3843, A3842, A3844, A3842, J0754, J0754, J0755,  J0752, J0798;  350-BAS-UK-10/ A3664, A3799, A3803, A3829,A3840,A3846, J0753, J0753, J0754, J0756;  350-BAS-AS-10/ A3656; 350-BAS-CF-10/ A3635, A3805, J0801;  350-BAS-CN-10/ A3633, A3636, A3805, A3833, J0801; 350-BAS-JA-08/ A3779  A3783, A3780, A3783, J0758, J0758;  350-BAS-KO-10/ J0753;  350-BAS-MS-10/ J0753; 350-BAS-USROW-10/ A3644; 360-BAS-AS-10/ A3656; 360-BAS-CN-10/ A3635; 360-BAS-KO-10/A3660 A3646, A3665, J0753, J0754;  360-BAS-SJ-10/ A3660; 450-BAS-JA-08/ A3779, A3783, A3788, A3821; 500-BAS-AS-10/ A3656; 500-BAS-CF-10/ A3635; 500-BAS-CN-10/ A3632, A3635, A3634, A3681; 500-BAS-KO-10/ A3660; 500-BAS-TH-10/ J0754, J0755, J0754; 500-BAS-UK-10/ A3654, A3654, A3664, A3664, A3765, A3787, A3801, A3840, J0753, J0755, J0754, J0756, J0748, J0798;   PAD-PAK-01/ A3632 A3633 A3634 A3635 A3636 A3637 A3642 A3656  A3657 A3657 A3657  A3662 A3669 A3681 A3678 A3682 A3766, A3777 A3778 A3781 A3782 A3805 A3807 A3833 A3833 A3834 A3834  A3832 A3840 J0759 J0761  J0760;  PAD-PAK-03/ A3638  A3639 A3640  A3658  A3644  A3644 A3655  A3666  A3653 A3652 A3641  A3643  A3660  A3664  A3665  A3672 A3663 A3668 A3667 A3661 A3659  A3764 A3765 A3770  A3772  A3773  A3774 A3775 A3776 A3779  A3784  A3785  A3786 A3787  A3787 A3785  A3799  A3799 A3800  A3801  A3802 A3802  A3803 A3804  A3829 A3829  A3840  A3845  A3846  A3847  A3849  A3849 A3845 J0749  J0749 J0748  J0750  J0751  J0752  J0753 J0753  J0754  J0756  J0786  J0786  J0790  J0791  J0787 J0788  J0788  J0789 J0792 J0792  J0795 J0794 J0793 J0792  J0796  J0797  J0798  J0799;  PAD-PAK-03j/ A3788 and A3821",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN,\tMO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA,\tVT,\tWA & WI and OUS (countries of): Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy,\tJapan, Korea, Netherlands, New Zealand, Peru, Poland, Singapore, South Africa, Spain, Thailand, & United Kingdom.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}