Landauer Radiation Dosimeter Recalled for Potential Measurement Inaccuracy
Landauer is recalling 1,880 units of the Constancy nanoDot D2DNN radiation dosimeter due to a potential non-conformance that may cause inaccurate radiation readings. The devices were distributed worldwide.
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 used for occupational radiation safety where potential measurement inaccuracy presents a risk to worker exposure assessment, but no illnesses or injuries have been reported and the hazard is theoretical.
Plain-English summary
Landauer is recalling 1,880 units of the Constancy (Cs-137) nanoDot D2DNN radiation monitoring dosimeter. The device is used to measure radiation exposure in occupational settings.
Reports indicated that some nanoDots may provide readings outside the specified accuracy range of ±5.5%. Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which converts radiation exposure into a fluorescent signal for measurement by microSTAR readers.
The recall affects all batch numbers of Model Numbers 18155-000 (EMEA number VKITCON001) and 18155-KIT, identified by UDI/DI 0860003399903. Distribution was worldwide.
Users who have these dosimeters should contact Landauer for information about this recall.
The recalled product
- Product
- Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Category
- Medical Device — Dosimetry
- Hazard
- Affected units
- 1,880
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.
See all 38 products in this recall →Related recalls
Same manufacturer · Landauer
See all →- ModerateLandauer microStar Reader dosimetry system discontinued for medical applications
FDA (Devices) · 2024-03-27
- HighLandauer microSTARii reader recalled for measurement inaccuracy
FDA (Devices) · 2024-01-03
- HighLandauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
FDA (Devices) · 2023-09-20
- HighLandauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2023-09-20
- HighLandauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
FDA (Devices) · 2023-09-20
Same hazard · measurement inaccuracy
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- ModeratePhilips Tempus Pro Patient Monitor Software Update for Operational Issues
FDA (Devices) · 2025-05-14
- SevereVentilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure
FDA (Devices) · 2024-11-20
- SevereAeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols
FDA (Devices) · 2024-11-20
- SevereTrilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation
FDA (Devices) · 2024-11-20