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
- Hazard
- Affected units
- 5,958
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.
Part of a larger recall action
This product is one of 38 recalled by Landauer under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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