Z-2228-2025Class I

DreamStation Auto BiPAP. Non-Continuous Ventilator

Name: Z-2228-2025 DreamStation Auto BiPAP. Non-Continuous Ventilator
Creator: Philips Respironics, Inc.
Published: 2025-06-30
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2025-06-30 / Open, Classified / root cause: manufacturing process

FDA source

Philips Respironics, Inc. began a recall of DreamStation Auto BiPAP. Non-Continuous Ventilator on 2025-06-30. FDA classified it as Class I and gives the reason as "Devices may possess a programming error resulting in an incorrect device configuration". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2228-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-06-30
Posted: 2025-08-08
Recalling firm: Respironics, Inc.
Product: DreamStation Auto BiPAP. Non-Continuous Ventilator.
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: Devices may possess a programming error resulting in an incorrect device configuration.
Root cause tag: manufacturing process
FDA 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 [email protected]. Consignees with any questions can contact Philips Respironics at 1-800-345-6443 (prompts 4, 5).
Quantity in commerce: 8 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.
Product codes and lots: Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2228-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2227-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08
Z-2228-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08
Z-2229-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08

Product code BZD

K131982Class IIRemstar Auto a-Flex HtRespironics, Inc. / cleared 2013-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)