fda
39 records
FDA Recall: Landauer — Class II
20240103
MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction | Product: Landauer microSTARii reader, Medical D...
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FDA Device Recall: microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110,
2024-03-27
Class II — 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 oth...
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FDA Device Recall: Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000
2024-01-03
Class II — 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 t...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: nanoDot D2DNS, Model Numbers: a) 18...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: nanoDot D2DNS, Model Numbers: a) 03...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: Constancy (80 kVp) nanoDot D2DNN, Mode...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: QC (80 kVp) screened nanoDot D2DNS, Mo...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: nanoDot A - item 1 of 3 for 03500-000,...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: Reader, nanoDot adapter, EU Model Numb...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: Calibrate (80 kVp) nanoDot D2DNS, Mode...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: nanoDot D2DNS, for custom calibrate, O...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: nanoDot kit (contains nanoDot A, B, C)...
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FDA Recall: Landauer — Class II
20230920
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo | Product: nanoDot D2DNS, for custom calibrate, O...
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FDA Device Recall: nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO;
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO;
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VK
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitor
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosime
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation mon
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monito
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation moni
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN00
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO;
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitor
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c)
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the m
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VK
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation mon
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO;
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation mon
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c)
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO;
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitor
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT;
2023-09-20
Class II — 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 potentia...
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FDA Device Recall: nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO;
2023-09-20
Class II — 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 potentia...
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ny_corps
2 records
NY Corp: LANDAUER PARTNERS LLC
2014-02-05
DOMESTIC LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: New York
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NY Corp: LANDAUER, INC.
2011-11-21
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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