BEUDAMED
    FDA Enforcement Class II Ongoing

    2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR

    Recall: Z-0734-2023 · Reported December 28, 2022

    Enforcement

    Recall Number
    Z-0734-2023
    Event ID
    91154
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2022
    Initiation Date
    July 27, 2022
    Classification Date
    December 20, 2022
    Address
    920 Winter St Bld 950, Waltham, MA, 02451-1521, United States

    Description

    2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR

    Reason

    (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".

    Code Info

    Software issue in SW versions 2.72 and earlier with CDX. UDI: (1) 00840861100897; (2) 00840861100910; (3) 00840861102082; (4) 00840861102099

    Distribution

    US Nationwide distribution.

    Quantity

    2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205