BEUDAMED
    FDA Enforcement Class II Ongoing

    Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]

    Recall: Z-1992-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1992-2023
    Event ID
    92353
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2023
    Initiation Date
    May 16, 2023
    Classification Date
    June 22, 2023
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]

    Reason

    The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

    Code Info

    All units shipped from January 20, 2020 through March 1, 2023; MU20503 (Resuscitaire) UDI - 04049098000215 MU20512 (Birthing Room Warmer - BRW) UDI - 04049098058001

    Distribution

    US Nationwide distribution including in the states of AL, AR, AZ, CA, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, VT, WA, and WI.

    Quantity

    936 units