# Landauer > Medical device manufacturer record on deviCERTS, compiled from public registries. 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. - Canonical page: - Country: not established - Role: Manufacturer ## Figures - Devices: 2 - FDA recalls (matched to the firm by name): 40 ## Registry facts *Every device of the manufacturer. A device listed in two registries counts in both.* - Registries: FDA 510(k) 1, FDA GUDID 1 - Device classes: FDA Class II 2 ## Devices The first 2 of 2, in the order of the canonical page, which lists them all. - [LANDAUER microSTAR® ii Dosimetry System](https://devicerts.com/devices/landauer-18000-000) · Class II · GUDID · status: Listed - [Medical Radiation Dosimetry System microSTARii](https://devicerts.com/devices/medical-radiation-dosimetry-system-microstarii-iye) · ref K192196 · Class II · 510(k) · status: Active · decision 2019-12-27 ## FDA recalls (matched by name, newest first) - Z-1349-2024 · Class II · Completed · initiated 2024-02-08 · product code LHO: 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. - Z-0616-2024 · Class II · Completed · initiated 2023-11-15 · product code IYE: 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. - Z-2538-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2539-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2540-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2541-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2542-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2543-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2544-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2545-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2546-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2547-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2548-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2549-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2550-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2551-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2552-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2553-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2554-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2555-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2556-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2557-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2558-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2559-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. - Z-2560-2023 · Class II · Completed · initiated 2023-07-12 · product code IYE: 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. ## Source and citation - Cite as: Landauer. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/landauer (data as of 2026-11-15). - Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - FDA recall data as of: 2026-11-01 - Data as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). 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 - 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.