FDA Medical Device Recalls (openFDA)
Philips Respironics, Inc.: DreamStation Auto. Non-Continuous Ventilator.
- Recall number
- Z-2229-2025
- Recalling firm
- Philips Respironics, Inc.
- Product
- DreamStation Auto. Non-Continuous Ventilator.
- Status
- Open, Classified
- Initiated
- 2025-06-30
- Posted
- 2025-08-08
- Terminated
- not on file
- Reason
- Devices may possess a programming error resulting in an incorrect device configuration.
- Root cause
- Process control
- 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 PatientSupport@philips.com. Consignees with any questions can contact Philips Respironics at 1-800-345-6443 (prompts 4, 5).
- Quantity
- 28 units
- 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.
- Lot, serial or model codes
- Model No. UFRX500S14; UDI: 606959069824; Serial No. J19093383C0FD, J195817171415, J195967969739, J1999161223D4, J208714453211, J21638786344A, J216718740A24, J22792026797C, J23016752559D, J23025544A4CA, J235207601E36, J236974697023, J24378890CB57, J24404277EDBB, J251606314EAA, J255220797791, J25755126C4A9, J262274772766, J26263484C9C9, J26377226BCF1, J26525214B253, J2661985603DE, J26673715FBD4, J27099876ED61, J272180530173, J27467764497E, J305016887150, J30708300FB50.
- 510(k) numbers
- ["K131982"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28