Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTA
FDA device recall Z-2550-2023 · posted 2023-09-12 · Completed
Recall details
- Recalling firm
- Landauer
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Completed
- Product code
- IYE
- Quantity affected
- 0
- Distribution
- Worldwide
- Date initiated
- 2023-07-12
- Date posted
- 2023-09-12
- Location
- Glenwood, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medical Radiation Dosimetry System microSTARii (K192196) | Landauer | 2019-12-27 |