Landauer microSTARii reader — Class II medical device recall Z-0616-2024
Completed recall by Landauer, reported 2024-01-03. MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways.
| Recall number | Z-0616-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Landauer, Glenwood, IL, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2023-12-22 |
| Reported by FDA | 2024-01-03 |
| Countries outside the US | AU, BR, CA, CN, DE, FR, IN, JP, KR, MX, TH, TW, VN |
| Quantity | 584 units |
| Model numbers | 18000-000/18001-000/18007-000 |
Product
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0616-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.