BEUDAMED
    FDA Recall Open, Classified

    DreamStation Auto. Non-Continuous Ventilator.

    Recall: Z-2229-2025 · Initiated June 30, 2025

    Recall

    Recall Number
    Z-2229-2025
    Event Number
    97191
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    BZD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 30, 2025
    Posted
    August 8, 2025
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    DreamStation Auto. Non-Continuous Ventilator.

    Reason

    Devices may possess a programming error resulting in an incorrect device configuration.

    Action

    Consignees were contacted by phone from 6/30/25 to 7/02/25 to facilitate provision of a replacement device. Additionally, a "Medical Device Recall Field Safety Notice" dated 6/6/2025 was sent to consignees instructing them to continue using their affected device until Philips Respironics can ship them a replacement. DMEs are to share the notice with those who need to be aware within their organization and to organizations where devices were transferred. If a consignee received the written notice but not a phone call from Philips Respironics, they are to call 1-877-387-3311 or email [email protected]. Consignees with any questions can contact Philips Respironics at 1-800-345-6443 (prompts 4, 5).

    Distribution

    Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France.

    Quantity

    28 units