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  "name": "(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845   Used with the following  MAGNETOM MRI Systems: MAGENTOM Amira   10836777 & 10838610; MAGENTOM Free.Max   11408424 & 11408425; MAGNETOM Free.Star   11408426 & 11408427; MAGNETOM Mica   11292557; MAGNETOM Sempra   10840815 & 10840816; MAGNETOM Spectra   10655588 & 10837643;  (2)  Over Ear Headphones   SMN: 11060845  used with the following MAGNETOM MRI systems: MAGENTOM Aera   10432914 MAGENTOM Altea   13344915 & 11410371 MAGNETOM Avanto   10849579 MAGNETOM Avanto Fit   11516216 MAGNETOM AvantoFit  10849578 MAGNETOM Cima.X   11647156 MAGNETOM Lumina   11344916 & 11516153 MAGNETOM Prisma   10849582 MAGNETOM PrismaFit   10849583 MAGNETOM Skyra   10432915 & 10849580 MAGNETOM Skrya Fit   11516217 MAGNETOM Sola   11291455 & 11410231 MAGNETOM Sola Fit   11410482 MAGNETOM Terra   10882764 MAGNETOM Terra.X   11371477 MAGNETOM Vida   11060815 & 11516152 MAGNETOM VidaFit   11410481",
  "description": "FDA recall Z-2648-2023 — Siemens Medical Solutions USA, Inc is recalling (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845   Used with the following  MAGNETOM MRI Systems: MAGENTOM Amira   10836777 & 10838610; MAGENTOM Free.Max   11408424 & 11408425; MAGNETOM Free.Star   11408426 & 11408427; MAGNETOM Mica   11292557; MAGNETOM Sempra   10840815 & 10840816; MAGNETOM Spectra   10655588 & 10837643;  (2)  Over Ear Headphones   SMN: 11060845  used with the following MAGNETOM MRI systems: MAGENTOM Aera   10432914 MAGENTOM Altea   13344915 & 11410371 MAGNETOM Avanto   10849579 MAGNETOM Avanto Fit   11516216 MAGNETOM AvantoFit  10849578 MAGNETOM Cima.X   11647156 MAGNETOM Lumina   11344916 & 11516153 MAGNETOM Prisma   10849582 MAGNETOM PrismaFit   10849583 MAGNETOM Skyra   10432915 & 10849580 MAGNETOM Skrya Fit   11516217 MAGNETOM Sola   11291455 & 11410231 MAGNETOM Sola Fit   11410482 MAGNETOM Terra   10882764 MAGNETOM Terra.X   11371477 MAGNETOM Vida   11060815 & 11516152 MAGNETOM VidaFit   11410481 (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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    "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-2648-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845   Used with the following  MAGNETOM MRI Systems: MAGENTOM Amira   10836777 & 10838610; MAGENTOM Free.Max   11408424 & 11408425; MAGNETOM Free.Star   11408426 & 11408427; MAGNETOM Mica   11292557; MAGNETOM Sempra   10840815 & 10840816; MAGNETOM Spectra   10655588 & 10837643;  (2)  Over Ear Headphones   SMN: 11060845  used with the following MAGNETOM MRI systems: MAGENTOM Aera   10432914 MAGENTOM Altea   13344915 & 11410371 MAGNETOM Avanto   10849579 MAGNETOM Avanto Fit   11516216 MAGNETOM AvantoFit  10849578 MAGNETOM Cima.X   11647156 MAGNETOM Lumina   11344916 & 11516153 MAGNETOM Prisma   10849582 MAGNETOM PrismaFit   10849583 MAGNETOM Skyra   10432915 & 10849580 MAGNETOM Skrya Fit   11516217 MAGNETOM Sola   11291455 & 11410231 MAGNETOM Sola Fit   11410482 MAGNETOM Terra   10882764 MAGNETOM Terra.X   11371477 MAGNETOM Vida   11060815 & 11516152 MAGNETOM VidaFit   11410481",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Siemens Medical Solutions USA, Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2648-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2648-2023: Siemens Medical Solutions USA, Inc is recalling (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845   Used with the following  MAGNETOM MRI Systems: MAGENTOM Amira   10836777 & 10838610; MAGENTOM Free.Max   11408424 & 11408425; MAGNETOM Free.Star   11408426 & 11408427; MAGNETOM Mica   11292557; MAGNETOM Sempra   10840815 & 10840816; MAGNETOM Spectra   10655588 & 10837643;  (2)  Over Ear Headphones   SMN: 11060845  used with the following MAGNETOM MRI systems: MAGENTOM Aera   10432914 MAGENTOM Altea   13344915 & 11410371 MAGNETOM Avanto   10849579 MAGNETOM Avanto Fit   11516216 MAGNETOM AvantoFit  10849578 MAGNETOM Cima.X   11647156 MAGNETOM Lumina   11344916 & 11516153 MAGNETOM Prisma   10849582 MAGNETOM PrismaFit   10849583 MAGNETOM Skyra   10432915 & 10849580 MAGNETOM Skrya Fit   11516217 MAGNETOM Sola   11291455 & 11410231 MAGNETOM Sola Fit   11410482 MAGNETOM Terra   10882764 MAGNETOM Terra.X   11371477 MAGNETOM Vida   11060815 & 11516152 MAGNETOM VidaFit   11410481",
      "text": "The FDA logged enforcement record Z-2648-2023: Siemens Medical Solutions USA, Inc is voluntarily recalling (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845   Used with the following  MAGNETOM MRI Systems: MAGENTOM Amira   10836777 & 10838610; MAGENTOM Free.Max   11408424 & 11408425; MAGNETOM Free.Star   11408426 & 11408427; MAGNETOM Mica   11292557; MAGNETOM Sempra   10840815 & 10840816; MAGNETOM Spectra   10655588 & 10837643;  (2)  Over Ear Headphones   SMN: 11060845  used with the following MAGNETOM MRI systems: MAGENTOM Aera   10432914 MAGENTOM Altea   13344915 & 11410371 MAGNETOM Avanto   10849579 MAGNETOM Avanto Fit   11516216 MAGNETOM AvantoFit  10849578 MAGNETOM Cima.X   11647156 MAGNETOM Lumina   11344916 & 11516153 MAGNETOM Prisma   10849582 MAGNETOM PrismaFit   10849583 MAGNETOM Skyra   10432915 & 10849580 MAGNETOM Skrya Fit   11516217 MAGNETOM Sola   11291455 & 11410231 MAGNETOM Sola Fit   11410482 MAGNETOM Terra   10882764 MAGNETOM Terra.X   11371477 MAGNETOM Vida   11060815 & 11516152 MAGNETOM VidaFit   11410481 — reason: In some cases, when lubricating grease is present  within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-01. Affected lots/codes: (1)Model/Material Number/UDI: MAGNETOM FREE.MAX 11408425   UDI: 04056869281742; MAGNETOM AMIRA 10836777  UDI: 04056869006819; MAGENTOM AMIRA 10838610 UDI: 04056869020488; MAGNETOM FREE.Max 11408424 UDI: 04056869281759; MAGNETOM Free.Star 11408426  UDI: 04056869281766; MAGNETOM Free.Star 11408427 UDI:  0405686981773; MAGNETOM Mica 11292557 NA; MAGNETOM Sempra 10840815  UDI: 04056869044521.  Over Ear Headphones   11060845 (Serial Numbers 7981 to 32200Serial Numbers; 7981 to 32200  (2) Model UDI-DI MAGNETOM AERA 10432914 04056869006697 MAGNETOM ALTEA 11344915 04056869230719  11410371 04056869230726 MAGNETOM AVANTO FIT 11516216 04056869299266 MAGNETOM AVANTOFit   10849578 04056869006642  10849579 04056869006659 MAGENTOM CIMA.X 11647158 04056869975221¿  11689304 04056869975245 MAGNETOM LUMINA 11344916 04056869230740  11516153 04056869260136 MAGENTOM PRISMA 10849582 04056869006727 MAGENTOM PRISMAFit 10849583 04056869006734 MAGNETOM SKYRA 10432915 04056869006703 MAGENTOM SKYRA 10849580 04056869006710 MAGENTOM SKYRA FIT 11516217 04056869299273 MAGNETOM SOLA 11291455 04056869164809  11410231 04056869217864 MAGNETOM SOLA FIT 11410482 04056869245195 MAGNETOM TERRA 10882764 04056869039190 MAGNETOM TERRA.X 11371477 04056869039190 MAGNETOM Viato.Mobile 11689652 04056869985558 MAGNETOM VIDA 11060815 04056869039176                           11516152 04056869260143 MAGNETOM VIDAFit 11410481 04056869245188   Over Ear Headphones   11060845 (Serial Numbers 7981 to 32200. 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-2648-2023&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-2648-2023&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-2648-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2648-2023 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-2648-2023&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-2648-2023&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-2648-2023/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."
    }
  ],
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      "name": "FDA recall details — Z-2648-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2648-2023",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        {
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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": "Siemens Medical Solutions USA, Inc",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "In some cases, when lubricating grease is present  within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-09-01",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "(1)Model/Material Number/UDI: MAGNETOM FREE.MAX 11408425   UDI: 04056869281742; MAGNETOM AMIRA 10836777  UDI: 04056869006819; MAGENTOM AMIRA 10838610 UDI: 04056869020488; MAGNETOM FREE.Max 11408424 UDI: 04056869281759; MAGNETOM Free.Star 11408426  UDI: 04056869281766; MAGNETOM Free.Star 11408427 UDI:  0405686981773; MAGNETOM Mica 11292557 NA; MAGNETOM Sempra 10840815  UDI: 04056869044521.  Over Ear Headphones   11060845 (Serial Numbers 7981 to 32200Serial Numbers; 7981 to 32200  (2) Model UDI-DI MAGNETOM AERA 10432914 04056869006697 MAGNETOM ALTEA 11344915 04056869230719  11410371 04056869230726 MAGNETOM AVANTO FIT 11516216 04056869299266 MAGNETOM AVANTOFit   10849578 04056869006642  10849579 04056869006659 MAGENTOM CIMA.X 11647158 04056869975221¿  11689304 04056869975245 MAGNETOM LUMINA 11344916 04056869230740  11516153 04056869260136 MAGENTOM PRISMA 10849582 04056869006727 MAGENTOM PRISMAFit 10849583 04056869006734 MAGNETOM SKYRA 10432915 04056869006703 MAGENTOM SKYRA 10849580 04056869006710 MAGENTOM SKYRA FIT 11516217 04056869299273 MAGNETOM SOLA 11291455 04056869164809  11410231 04056869217864 MAGNETOM SOLA FIT 11410482 04056869245195 MAGNETOM TERRA 10882764 04056869039190 MAGNETOM TERRA.X 11371477 04056869039190 MAGNETOM Viato.Mobile 11689652 04056869985558 MAGNETOM VIDA 11060815 04056869039176                           11516152 04056869260143 MAGNETOM VIDAFit 11410481 04056869245188   Over Ear Headphones   11060845 (Serial Numbers 7981 to 32200",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}