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Recall Observatory FDA recall evidence

Device product

Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000

Z-0616-2024

November 15, 2023

Class II

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

    reason.no_named_rule · v1.0.0

    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.