BEUDAMED
    FDA Enforcement Class III Terminated

    2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

    Recall: Z-1699-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1699-2019
    Event ID
    82729
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    April 3, 2019
    Classification Date
    May 31, 2019
    Termination Date
    August 30, 2019
    Address
    920 Winter St, Waltham, MA, 02451-1521, United States

    Description

    2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

    Reason

    Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

    Code Info

    Software v.2.72

    Distribution

    US Nationwide distribution.

    Quantity

    257 units