FDA Device recall Z-0616-2024
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
- FDA Device
- Class II
- completed
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 by Landauer, citing 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 prof….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0616-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-11-15 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Landauer |
| Distribution | n/a |
Product
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Reason
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.
Identifiers
| code_info | All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0616-2024%22
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