DreamStation Auto CPAP. Non-Continuous Ventilator.
FDA Recall Z-2227-2025 · Posted 2025-08-08
Recalling FirmPhilips Respironics, Inc.
Recall StatusOpen, Classified
Product CodeBZD
Date Initiated2025-06-30
Product Quantity57 units
Reason for Recall
Devices may possess a programming error resulting in an incorrect device configuration.
Firm 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).
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.