The Recall Desk
HighFDA (Devices)·Z-2546-2023·Announced 2023-09-20

Medical Device: Radiation Dosimeter Units May Have Inaccurate Readings

Landauer nanoDot D2DXN radiation dosimeters may measure outside the specified +/-5.5% accuracy range due to a potential non-conformance in the optical stimulated luminescence material. Approximately 13,950 units 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 recall of a radiation measurement device with potential accuracy outside manufacturer specifications. No illnesses or injuries reported, but inaccurate dosimetry presents a risk of occupational health harm if workers receive inadequate radiation exposure assessment.

Plain-English summary

Landauer is recalling nanoDot D2DXN radiation monitoring dosimeters (Model Numbers 03061-1MO, 03061-3MO, 03061-OTO, 03061-SMO) used with microSTAR readers. The manufacturer identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material within the dosimeter that could result in measurement inaccuracy.

The dosimeters may measure radiation exposure outside the specified range of +/-5.5% accuracy. Because these devices are used to monitor occupational radiation exposure, inaccurate readings could result in workers receiving inadequate assessment of their radiation exposure.

Approximately 13,950 units have been distributed worldwide. The affected units are identified by UDI/DI 0860003399903 with all batch numbers.

Users of these dosimeters, including healthcare facilities and radiation safety professionals, should contact Landauer for guidance on verification, replacement, or remediation of affected units. Do not rely on potentially affected devices for radiation exposure monitoring until verification is completed.

The recalled product

Product
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Dosimeter
Hazard
  • measurement-inaccuracy
  • radiation-exposure

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