Date Initiated by Firm |
July 12, 2023 |
Date Posted |
September 12, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2561-2023 |
Recall Event ID |
92647 |
510(K)Number |
K192196
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers |
Code Information |
UDI/DI 0860003399903, all batch numbers |
Recalling Firm/ Manufacturer |
Landauer 2 Science Rd Glenwood IL 60425-1531
|
For Additional Information Contact |
Brian Malone 815-690-1231
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
632928 units |
Distribution |
Worldwide |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = Landauer
|