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U.S. Department of Health and Human Services

Class 2 Device Recall nanoDot

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  Class 2 Device Recall nanoDot see related information
Date Initiated by Firm July 12, 2023
Date Posted September 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-2573-2023
Recall Event ID 92647
510(K)Number K192196  
Product Classification Accelerator, linear, medical - Product Code IYE
Product NanoDots, Model Numbers:
a) BC30023, description: QC Set For Microstar Dots;
b) BC30083, description: nanoDot QC Set - 80kVp - Sale;
c) BC30084, description: nanoDot QC Set - 80kVp - No Charge;
d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge;
e) BC30095, description: Dot, D1DNN, in carrier sealed in bag;
f) BC30110, description: Calibration set, nanoDot;
g) BC30141, description: nanoDot QC Set - Cs137 - Sale;
h) BC30142, description: nanoDot Calibration set - Cs137 - Sale; 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 18333 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
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