Landauer recalls QC (80 kVp) nanoDot D2DNS radiation dosimeters due to potential inaccuracy in radiation measurement. Affected models include 04218-000, 04218-KIT, and 04218-SET.
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.
Landauer is recalling QC (80 kVp) nanoDot D2DNS radiation dosimeters because some units may be outside the specified accuracy range of +/-5.5%. This could lead to incorrect radiation exposure readings, potentially affecting safety in medical settings.
The dosimeters may not measure radiation exposure accurately within the specified +/-5.5% range. This could result in incorrect radiation dose readings, potentially leading to unsafe exposure levels for patients or staff during medical procedures.
Medical facilities using Landauer nanoDot D2DNS radiation dosimeters with model numbers 04218-000, 04218-KIT, or 04218-SET are most at risk. Patients and staff in these settings may be affected if the dosimeters provide inaccurate radiation measurements.
Check for model numbers 04218-000 (EMEA number VINLNAN004), 04218-KIT, or 04218-SET on the dosimeter. These units were sold with the UDI/DI 0860003399903 and all batch numbers.
Identify the model number on your nanoDot D2DNS dosimeter to see if it matches 04218-000, 04218-KIT, or 04218-SET.
Landauer received reports that some nanoDots may be outside the specified accuracy range of +/-5.5%, indicating potential non-conformance in the Optical Stimulated Luminescence (OSL) material.
The affected models are 04218-000 (EMEA number VINLNAN004), 04218-KIT, and 04218-SET.
Check the model number on your dosimeter; if it is 04218-000, 04218-KIT, or 04218-SET, it is affected.
We’ve drafted a message you can send Landauer to request your refund or repair — edit it as you like.
Subject: Recall Z-2558-2023 — Landauer Landauer Hello, I own a Landauer that is covered by recall Z-2558-2023 from Landauer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
