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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0551-2025.jsonld",
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  "name": "Merlin@home Transmitter REF EX1100    The Merlin@home\" (M@h) transmitter is intended to transfer stored data from  the patient s implanted heart device to Merlin.net\" Patient Care Network (PCN)  to facilitate remote monitoring by using inductive (EX1100 Model) or RF  telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net  PCN server.",
  "description": "FDA recall Z-0551-2025 — Abbott Medical is recalling Merlin@home Transmitter REF EX1100    The Merlin@home\" (M@h) transmitter is intended to transfer stored data from  the patient s implanted heart device to Merlin.net\" Patient Care Network (PCN)  to facilitate remote monitoring by using inductive (EX1100 Model) or RF  telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net  PCN server. (Devices, Class III). 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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    "@type": "schema:Dataset",
    "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-0551-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Merlin@home Transmitter REF EX1100    The Merlin@home\" (M@h) transmitter is intended to transfer stored data from  the patient s implanted heart device to Merlin.net\" Patient Care Network (PCN)  to facilitate remote monitoring by using inductive (EX1100 Model) or RF  telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net  PCN server.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Abbott Medical"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0551-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0551-2025: Abbott Medical is recalling Merlin@home Transmitter REF EX1100    The Merlin@home\" (M@h) transmitter is intended to transfer stored data from  the patient s implanted heart device to Merlin.net\" Patient Care Network (PCN)  to facilitate remote monitoring by using inductive (EX1100 Model) or RF  telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net  PCN server.",
      "text": "The FDA logged enforcement record Z-0551-2025: Abbott Medical is voluntarily recalling Merlin@home Transmitter REF EX1100    The Merlin@home\" (M@h) transmitter is intended to transfer stored data from  the patient s implanted heart device to Merlin.net\" Patient Care Network (PCN)  to facilitate remote monitoring by using inductive (EX1100 Model) or RF  telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net  PCN server. — reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-01. Affected lots/codes: Model Number: EX1100 UDI-DI code: Pending Serial Numbers: 12600224 12600307 12600895 12600974 12601074 12601156 12601169 12602176 12602216 12602464 12602491 12604265 12604852 12606254 12606332 12606531 12606550 12606551 12606587 12606785 12606814 12607289 12607557 12608093 12608346 12608623 12608678 12608758 12608819 12609094 12609148 12609819 12609919 12610472 12610550 12611493 12611733 12611975 12612409 12612417 12612541 12612929 12613146 12613636 12617342 12617350 12617583 12617821 12618054 12618130 12618726 12618782 12619218 12619405 12619515 12619825 12619827 12620745 12621171 12622233 12622283 12622473 12623904 12625575 12625701 12625874 12628403 12628624 12628626 12634096 12634120 12634141 12634152 12634208 12635184 12635287 12636062 12636067 12636127 12636195 12638900 12639020 12640950 12641103 12641819 12643036 12643543 12643551 12643589 12643621 12643623 12643640 12643744 12643781 12643792 12647278 12647327 12647343 12647350 12647621 12647781 12647787 12647789 12647904 12647923 12647939 12647940 12648513 12648520 12648589 12648611 12648704 12648839 12649443 12649481 12649517 12650938 12651018 12651022 12651051 12651056 12651073 12651198 12651419 12651476 12651597 12652036 12652060 12652070 12652076. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
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        "occurred": true,
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        "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-0551-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-0551-2025&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-0551-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0551-2025 as Class III",
      "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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
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      "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-0551-2025&lang=eng",
        "value": "Class III",
        "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-0551-2025&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-0551-2025/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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
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        "adjudged": false,
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        "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."
    }
  ],
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      "name": "FDA recall details — Z-0551-2025",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-0551-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class III",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Abbott Medical",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-10-01",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model Number: EX1100 UDI-DI code: Pending Serial Numbers: 12600224 12600307 12600895 12600974 12601074 12601156 12601169 12602176 12602216 12602464 12602491 12604265 12604852 12606254 12606332 12606531 12606550 12606551 12606587 12606785 12606814 12607289 12607557 12608093 12608346 12608623 12608678 12608758 12608819 12609094 12609148 12609819 12609919 12610472 12610550 12611493 12611733 12611975 12612409 12612417 12612541 12612929 12613146 12613636 12617342 12617350 12617583 12617821 12618054 12618130 12618726 12618782 12619218 12619405 12619515 12619825 12619827 12620745 12621171 12622233 12622283 12622473 12623904 12625575 12625701 12625874 12628403 12628624 12628626 12634096 12634120 12634141 12634152 12634208 12635184 12635287 12636062 12636067 12636127 12636195 12638900 12639020 12640950 12641103 12641819 12643036 12643543 12643551 12643589 12643621 12643623 12643640 12643744 12643781 12643792 12647278 12647327 12647343 12647350 12647621 12647781 12647787 12647789 12647904 12647923 12647939 12647940 12648513 12648520 12648589 12648611 12648704 12648839 12649443 12649481 12649517 12650938 12651018 12651022 12651051 12651056 12651073 12651198 12651419 12651476 12651597 12652036 12652060 12652070 12652076",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.",
            "Status": "recorded"
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