Radiation monitoring dosimeter recalled for potential measurement inaccuracy
Landauer is recalling Calibrate nanoDot radiation monitoring dosimeters due to a potential defect in the optical luminescence material that may result in inaccurate radiation dose readings.
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: FDA Class II medical device recall with no reported injuries or illnesses. The defect creates risk of inaccurate radiation exposure measurement—a safety-critical function—but the hazard is theoretical with no reported harm.
Plain-English summary
Landauer is recalling Calibrate (80 kVp) nanoDot D2DNS radiation monitoring dosimeters (Model Numbers 18120-000, 18120-KIT, and 18120-SET). Approximately 3,947 units have been distributed worldwide.
Investigation of these dosimeters found a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which is designed to emit fluorescence proportional to received radiation when stimulated. Some dosimeters may be outside the specified accuracy range of ±5.5%. This defect could cause inaccurate radiation dose readings.
Radiation monitoring dosimeters are critical safety devices used in medical facilities, research laboratories, and industrial settings to track occupational and patient radiation exposure. Inaccurate readings could compromise worker and patient safety by providing false radiation exposure data.
The recalled product
- Product
- Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- dosimetry-error
- inaccurate-measurement
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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