Landauer Recall 92647
Description: Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
Landauer Recall 92647 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2571-2023 |
| Event ID | 92647 |
| Event Description | Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers |
| Product Type | Devices |
| Distribution | Worldwide |
| Quantity | 512 units |
| Recall 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. |
| Device Classification | 20230920 |
| Device Code Info | UDI/DI 0860003399903, all batch numbers |
| Center Classification Date | 20230912 |
| Recall Initiation Date | 20230712 |
| Recalling Firm | Landauer |
| Initial Notification | Letter |
| Similar To |