Device product
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radiation monitoring dosimeter used with the microSTAR readers
Z-2560-2023
Product summary
- Firm
- Landauer
- Event
- Event 92647
- Status
- Completed
- Classification
- Class II
- Quantity
- 1440 units
- Official record key
device-enforcement:Z-2560-2023
Official wording
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.
Code information: UDI/DI 0860003399903, all batch numbers
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
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.