{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0996-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:    CT900A PROG CT900A CLINICIAN TABLET US  CT900B PROG CT900B CLINICIAN TABLET EU -UK  CT900C PROG CT900C CLINICIAN TABLET UK  CT900D PROG CT900D CLINICIAN TABLET GLOBAL  CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG  CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG",
  "description": "FDA recall Z-0996-2026 — Medtronic Neuromodulation is recalling Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:    CT900A PROG CT900A CLINICIAN TABLET US  CT900B PROG CT900B CLINICIAN TABLET EU -UK  CT900C PROG CT900C CLINICIAN TABLET UK  CT900D PROG CT900D CLINICIAN TABLET GLOBAL  CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG  CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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-0996-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:    CT900A PROG CT900A CLINICIAN TABLET US  CT900B PROG CT900B CLINICIAN TABLET EU -UK  CT900C PROG CT900C CLINICIAN TABLET UK  CT900D PROG CT900D CLINICIAN TABLET GLOBAL  CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG  CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medtronic Neuromodulation"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0996-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0996-2026: Medtronic Neuromodulation is recalling Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:    CT900A PROG CT900A CLINICIAN TABLET US  CT900B PROG CT900B CLINICIAN TABLET EU -UK  CT900C PROG CT900C CLINICIAN TABLET UK  CT900D PROG CT900D CLINICIAN TABLET GLOBAL  CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG  CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG",
      "text": "The FDA logged enforcement record Z-0996-2026: Medtronic Neuromodulation is voluntarily recalling Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:    CT900A PROG CT900A CLINICIAN TABLET US  CT900B PROG CT900B CLINICIAN TABLET EU -UK  CT900C PROG CT900C CLINICIAN TABLET UK  CT900D PROG CT900D CLINICIAN TABLET GLOBAL  CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG  CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG — reason: Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-20. Affected lots/codes: CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected  The implanted devices are not affected.. 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-0996-2026&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-0996-2026&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-0996-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0996-2026 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-0996-2026&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-0996-2026&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-0996-2026/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."
    }
  ],
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0996-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0996-2026",
            "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 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": "Medtronic Neuromodulation",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-11-20",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected  The implanted devices are not affected.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia,  Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China,  Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt,  El Salvador, Finland, France, French Polynesia, Germany, Greece, Guatemala, Hong Kong,  Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia,  Malta, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Panama,  Peru, Poland, Portugal, Qatar, Reunion, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.",
            "Status": "recorded"
          }
        }
      ]
    }
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}