The Recall Desk
HighFDA (Devices)·Z-2548-2023·Announced 2023-09-20

Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy

Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II medical device recall with a safety-relevant defect in a radiation dosimeter. Measurement inaccuracy could affect radiation protection adequacy. No injuries or illnesses reported, and the defect is described as potential rather than confirmed.

Plain-English summary

Landauer is recalling the nanoDot D2DXS radiation monitoring dosimeter (Model Numbers 03063-1MO, 03063-3MO, 03063-OTO, and 03063-SMO). The recall involves approximately 68,007 units distributed worldwide.

The recalled dosimeters may not accurately measure radiation exposure. Investigation found a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in the device. Some units may fall outside the specified accuracy range of ±5.5%.

No injuries or illnesses have been reported. Users who have these dosimeters should contact Landauer for further information.

The recalled product

Product
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device
Hazard
  • measurement-inaccuracy
  • radiation-exposure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 0860003399903
  • all batch numbers

Distribution

Distribution scope not specified by the agency.

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