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Open, Classified

DreamStation Auto BiPAP. Non-Continuous Ventilator.

FDA Recall Z-2228-2025 · Posted 2025-08-08

Recall StatusOpen, Classified
Product CodeBZD
Date Initiated2025-06-30
Product Quantity8 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.

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