BEUDAMED
    FDA Enforcement Class II Ongoing

    Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access

    Recall: Z-2100-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2100-2019
    Event ID
    83302
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ASTRA, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    April 25, 2019
    Classification Date
    August 7, 2019
    Address
    282 Century Lane, N/A, Louisville, CO, 80027, United States

    Description

    Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access

    Reason

    Failure to comply event due to incorrect labeling of a class 1 laser product.

    Code Info

    Model: L1, identified by Accession No. RH19A0069

    Distribution

    US Nationwide Distribution

    Quantity

    1 product