Philips Respironics, Inc.: Device Recall

Recall #Z-2228-2025 · 06/30/2025

Class I: Dangerous

Recall Details

Recall Number: Z-2228-2025
Classification: Class I
Product Type: Device
Recalling Firm: Philips Respironics, Inc.
Status: Ongoing
Date Initiated: 06/30/2025
Location: Murrysville, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8 units

Reason for Recall

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

Product Description

DreamStation Auto BiPAP. Non-Continuous Ventilator.

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.

Other Recalls by Philips Respironics, Inc.

Class II: Risk 10/07/2025

Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
Class I: Dangerous 06/30/2025

Devices may possess a programming error resulting in an incorrect device configuration.
Class I: Dangerous 06/30/2025

Devices may possess a programming error resulting in an incorrect device configuration.
Class I: Dangerous 05/09/2025

This device does not indicate for use in patients with respiratory failure.
Class I: Dangerous 05/09/2025

This device does not indicate for use in patients with respiratory failure.

View all recalls by Philips Respironics, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.