Philips Respironics, Inc. recalls DreamStation Auto BiPAP. Non-Continuous Ventilator.

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

DreamStation Auto BiPAP. Non-Continuous Ventilator.

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 PatientSupport@philips.com. Consignees with any questions can contact Philips Respironics at 1-800-345-6443 (prompts 4, 5).

• FDA enforcement recordOfficial FDA database entry for Z-2228-2025
• FDA 510(k) clearance · K131982The device's official FDA premarket clearance record
• FDA device classification · BZDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5905The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips Respironics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.