BEUDAMED
    FDA Enforcement Class II Completed

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

    Recall: Z-0616-2024 · Reported January 3, 2024

    Enforcement

    Recall Number
    Z-0616-2024
    Event ID
    93524
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Landauer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 3, 2024
    Initiation Date
    November 15, 2023
    Classification Date
    December 22, 2023
    Address
    2 Science Rd, Glenwood, IL, 60425-1531, United States

    Description

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

    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 Info

    All serial numbers.

    Distribution

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

    Quantity

    584 units