The Recall Desk
HighFDA (Devices)·Z-2560-2023·Announced 2023-09-20

Landauer nanoDot radiation dosimeter may report inaccurate dose readings

Landauer is recalling certain nanoDot radiation dosimeters worldwide due to a potential flaw in the optical stimulated luminescence material. Affected devices may provide 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: This is a Class II recall involving potential measurement inaccuracy in a radiation dosimeter. Although no illnesses or injuries have been reported, the defect represents a risk-of-harm to workers who depend on these devices for radiation protection monitoring.

Plain-English summary

Landauer is recalling certain QC (Cs-137) nanoDot D2DNS radiation monitoring dosimeters due to a potential accuracy issue. Affected model numbers are 04225-000 (EMEA number VINLNAN005), 04225-KIT, and 04225-SET, with approximately 1440 units distributed worldwide under UDI/DI 0860003399903, all batch numbers.

Landauer received reports indicating that some nanoDots may fall outside the specified accuracy range of plus or minus 5.5 percent. Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material within the dosimeters. When exposed to radiation, this OSL material is designed to emit fluorescence proportional to the radiation dose received. If the material is defective, the fluorescence output may not accurately reflect the actual radiation exposure, resulting in potentially inaccurate dose readings.

These dosimeters are used in radiation monitoring applications where accurate dose measurement is critical. Customers and healthcare facilities with affected devices are advised to contact Landauer for information about proper use, recalibration, testing, or potential replacement of their devices. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Monitoring
Hazard
  • inaccurate-measurement
  • material-defect

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

Same category