medical Class II Updated 2024-01-03

Landauer recalls Landauer microSTARii reader, Medical Dosimetry System, Model

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam

Lot/Code Info: All serial numbers.

View official government recall

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