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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2571-2023
Event ID92647
Event DescriptionConstancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
Product TypeDevices
DistributionWorldwide
Quantity512 units
Recall ReasonLANDAUER 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 Classification20230920
Device Code InfoUDI/DI 0860003399903, all batch numbers
Center Classification Date20230912
Recall Initiation Date20230712
Recalling FirmLandauer
Initial Notification Letter
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