Landauer

FDA Regulatory Profile

Summary

Total Recalls
40
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1349-2024Class IImicroStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 February 8, 2024
Z-0616-2024Class IILandauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000November 15, 2023
Z-2565-2023Class IICalibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radJuly 12, 2023
Z-2545-2023Class IInanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiaJuly 12, 2023
Z-2568-2023Class IIQC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiationJuly 12, 2023
Z-2552-2023Class IIQC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used withJuly 12, 2023
Z-2559-2023Class IICalibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 0422July 12, 2023
Z-2561-2023Class IInanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used July 12, 2023
Z-2569-2023Class IIQC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiationJuly 12, 2023
Z-2558-2023Class IIQC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; July 12, 2023
Z-2562-2023Class IInanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiaJuly 12, 2023
Z-2553-2023Class IInanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used July 12, 2023
Z-2560-2023Class IIQC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; July 12, 2023
Z-2574-2023Class IINanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readersJuly 12, 2023
Z-2571-2023Class IIConstancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 1815July 12, 2023
Z-2567-2023Class IIQC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiationJuly 12, 2023
Z-2554-2023Class IInanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used wJuly 12, 2023
Z-2575-2023Class IIReader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the miJuly 12, 2023
Z-2563-2023Class IInanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used wJuly 12, 2023
Z-2564-2023Class IICalibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; raJuly 12, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K192196Medical Radiation Dosimetry System microSTARiiDecember 27, 2019