Landauer Recall 93524
Description: Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Landauer Recall 93524 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0616-2024 |
| Event ID | 93524 |
| Event Description | Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 |
| Product Type | Devices |
| Distribution | US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam |
| Quantity | 584 units |
| Recall 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. |
| Device Classification | 20240103 |
| Device Code Info | All serial numbers. |
| Center Classification Date | 20231222 |
| Recall Initiation Date | 20231115 |
| Recalling Firm | Landauer |
| Initial Notification | |
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