Recall Z-2228-2025— Philips Respironics, Inc.

Name: FDA recall Z-2228-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-30

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2025-06-30. It names one FDA 510(k) clearance: K131982. Product: DreamStation Auto BiPAP. Non-Continuous Ventilator.. Reason: Devices may possess a programming error resulting in an incorrect device configuration..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-06-30
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K131982 — REMSTAR AUTO A-FLEX HTRespironics, Inc.·cleared 2013-10-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DreamStation Auto BiPAP. Non-Continuous Ventilator.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.