Device product
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Z-0616-2024
Product summary
- Firm
- Landauer
- Event
- Event 93524
- Status
- Completed
- Classification
- Class II
- Quantity
- 584 units
- Official record key
device-enforcement:Z-0616-2024
Official wording
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.
Code information: All serial numbers.
Distribution pattern: US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
Derived failure modes
-
Unknown
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.