{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Landauer. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/landauer (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/landauer",
    "json_url": "https://devicerts.com/manufacturers/landauer.json",
    "markdown_url": "https://devicerts.com/manufacturers/landauer.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/landauer",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Landauer",
    "url": "https://devicerts.com/manufacturers/landauer",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": null,
    "country_basis": null,
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [],
    "summary": "Landauer is a medical device manufacturer, with 2 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) and 40 FDA recalls as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 2,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 40,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA 510(k)",
        "devices": 1
      },
      {
        "registry": "FDA GUDID",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 2
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 2,
    "total": 2,
    "all_devices_url": "https://devicerts.com/manufacturers/landauer",
    "items": [
      {
        "name": "LANDAUER microSTAR® ii Dosimetry System",
        "url": "https://devicerts.com/devices/landauer-18000-000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Medical Radiation Dosimetry System microSTARii",
        "url": "https://devicerts.com/devices/medical-radiation-dosimetry-system-microstarii-iye",
        "model_reference": "K192196",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2019-12-27",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1349-2024",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2024-02-08",
      "product_code": "LHO",
      "reason": "Permanent discontinuance of the microSTARii medical dosimetry system.  Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications."
    },
    {
      "number": "Z-0616-2024",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-11-15",
      "product_code": "IYE",
      "reason": "MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction of the reader s LED beam profile with the nanoDot dosimeter. The second is debris formation due to drawer actuation, resulting in a change of reader response that may not be detectable unless known dose QCs are being run regularly."
    },
    {
      "number": "Z-2538-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2539-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2540-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2541-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2542-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2543-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2544-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2545-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2546-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2547-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2548-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2549-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2550-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2551-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2552-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2553-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2554-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2555-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2556-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2557-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2558-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2559-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    },
    {
      "number": "Z-2560-2023",
      "classification": "Class II",
      "status": "Completed",
      "initiated": "2023-07-12",
      "product_code": "IYE",
      "reason": "LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure."
    }
  ]
}