FDA-Device2024-01-03Class II
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Landauer
Hazard
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.
Sold states
US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
Affected count
584 units
Manufactured in
2 Science Rd, Glenwood, IL, United States
Products
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0616-2024Don't want to check this manually?
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