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  "name": "RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.",
  "description": "FDA recall Z-1482-2024 — RAYSEARCH LABORATORIES AB is recalling RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs. (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": "RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1482-2024/enforcement-record",
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      "name": "FDA recall Z-1482-2024: RAYSEARCH LABORATORIES AB is recalling RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.",
      "text": "The FDA logged enforcement record Z-1482-2024: RAYSEARCH LABORATORIES AB is voluntarily recalling RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs. — reason: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-23. Affected lots/codes: Version Number (Build Number/UDI): 8B (8.1.0.47/07350002010129), 8B SP1 (8.1.1.8/07350002010204), 8B SP2 (8.1.2.5/07350002010235), 9A (9.0.0.113/07350002010174), 9A SP1 (9.0.1.142/07350002010488), 9B (9.1.0.933/07350002010266), 9B SP1 (9.2.0.483/07350002010297), 10A (10.0.0.1154/07350002010303), 10A SP1 (10.0.1.52/07350002010365), 10A SP2 (10.0.2.10/07350002010655), 10B (10.1.0.613/07350002010310), 10B SP1 (10.1.1.54/07350002010471), 11A (11.0.0.951/07350002010389), 11A SP1 (11.0.1.29/07350002010433), 11A SP2 (11.0.3.116/07350002010440), 11A SP3 (11.0.4.15/07350002010631), 11B (12.0.0.932/07350002010426), 11B SP1 (12.1.0.1221/07350002010495), 11B SPC1 (12.1.1.41/07350002010587), 11B SP2 (12.0.3.68/07350002010501), 11B SPC2 (12.1.2.91/07350002010617), 11B SP3 (12.0.4.12/07350002010600), 11B SPC3 (12.1.3.162/07350002010662), 11B SPC4 (12.1.4.113/07350002010709), 11B SPC5 (12.1.5.60/07350002010747), 11B SPT1 (12.3.0.119/07350002010570), 12A (13.0.0.1547/07350002010549), 12A SP1 (13.1.0.144/07350002010679), 12A SP2 (13.1.1.89/07350002010730), 2023B (14.0.0.3338/07350002010556), 2024A (15.0.0.430/07350002010723),. A RECORDED FDA enforcement action (occurred=true).",
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1482-2024/fda-classification",
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      "name": "FDA classified recall Z-1482-2024 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",
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        "supported": true,
        "adjudged": true,
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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-1482-2024/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.",
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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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      "name": "FDA recall details — Z-1482-2024",
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            "Value": "Devices",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "RAYSEARCH LABORATORIES AB",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-02-23",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Version Number (Build Number/UDI): 8B (8.1.0.47/07350002010129), 8B SP1 (8.1.1.8/07350002010204), 8B SP2 (8.1.2.5/07350002010235), 9A (9.0.0.113/07350002010174), 9A SP1 (9.0.1.142/07350002010488), 9B (9.1.0.933/07350002010266), 9B SP1 (9.2.0.483/07350002010297), 10A (10.0.0.1154/07350002010303), 10A SP1 (10.0.1.52/07350002010365), 10A SP2 (10.0.2.10/07350002010655), 10B (10.1.0.613/07350002010310), 10B SP1 (10.1.1.54/07350002010471), 11A (11.0.0.951/07350002010389), 11A SP1 (11.0.1.29/07350002010433), 11A SP2 (11.0.3.116/07350002010440), 11A SP3 (11.0.4.15/07350002010631), 11B (12.0.0.932/07350002010426), 11B SP1 (12.1.0.1221/07350002010495), 11B SPC1 (12.1.1.41/07350002010587), 11B SP2 (12.0.3.68/07350002010501), 11B SPC2 (12.1.2.91/07350002010617), 11B SP3 (12.0.4.12/07350002010600), 11B SPC3 (12.1.3.162/07350002010662), 11B SPC4 (12.1.4.113/07350002010709), 11B SPC5 (12.1.5.60/07350002010747), 11B SPT1 (12.3.0.119/07350002010570), 12A (13.0.0.1547/07350002010549), 12A SP1 (13.1.0.144/07350002010679), 12A SP2 (13.1.1.89/07350002010730), 2023B (14.0.0.3338/07350002010556), 2024A (15.0.0.430/07350002010723),",
            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, P.R. China, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom.",
            "Status": "recorded"
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}