Recall Z-2540-2023 ยท IYE Accelerator, Linear, Medical
Landauer
nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers
| Date | Sep 12, 2023 (initiated Jul 12, 2023) |
| Status | Completed |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Landauer disseminated an URGENT - Medical Device Recall notice to its consignees on 07/12/2023 by US mail and email. The notice explained the problem with the devices, potential risk, and requested the following: Discontinue use of the affected products, destroy used products, and return unused products. |
| Quantity | 5760 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192196 | Medical Radiation Dosimetry System microSTARii Landauer, Dec 27, 2019 |