microSTARii Reader (Landauer) – Dosimeter Measurement (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Lot Codes / Batch Numbers
All serial numbers.
Products Sold
All serial numbers.
A medical device manufacturer is recalling Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 due to MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction of the reader s LED beam profile with the nanoDot dosimeter. The second is debris formation due to drawer actuation, resulting in a change of reader response that may not be detectable unless known dose QCs are being run regularly.
Recommended Action
Per FDA guidance
Landauer Issued an URGENT - Medical Device Recall notice to its consignees on 11/15/2023 via email. The notice explained the issue, potential risk, and requested return of the device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026