The Recall Desk
HighFDA (Devices)·Z-2557-2023·Announced 2023-09-20

Radiation Dosimeter May Provide Inaccurate Dose Measurements

Landauer is recalling certain nanoDot D2DNS radiation dosimeters because they may measure radiation exposure outside the specified accuracy range. Approximately 5,958 units worldwide are affected.

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: This Class II medical device may provide inaccurate radiation measurements. Although the potential non-conformance is not confirmed, the risk of measurement inaccuracy in a dosimeter creates a risk-of-harm scenario for workers relying on accurate exposure monitoring.

Plain-English summary

Landauer is recalling Calibrate (80 kVp) nanoDot D2DNS radiation monitoring dosimeters (Model Numbers 04217-000, 04217-KIT, and 04217-SET) used with microSTAR readers. Approximately 5,958 units have been distributed worldwide. The devices are designed to measure occupational radiation exposure.

Some nanoDots may be outside the specified +/-5.5% accuracy range for radiation measurement. Landauer's investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used by the device to measure radiation exposure.

Users should contact Landauer to verify whether their dosimeters are affected and to obtain corrected or replacement units.

The recalled product

Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Dosimeter
Hazard
  • measurement-inaccuracy

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.

Related recalls

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