Food, drugs, devices › Philips Respironics, Inc.
Device recall: DreamStation Auto CPAP. Non-Continuous Ventilator.
Philips Respironics, Inc. (Murrysville, PA) initiated this device recall on 30 Jun 2025; FDA lists 3 product records under event 97191, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips Respironics, Inc. has 26 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Respironics, Inc., Murrysville, PA.
Reason for recall
"Devices may possess a programming error resulting in an incorrect device configuration."
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 records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2227-2025 | DreamStation Auto CPAP. Non-Continuous Ventilator. | 57 units | Class I | Ongoing | 20 Aug 2025 |
| Z-2228-2025 | DreamStation Auto BiPAP. Non-Continuous Ventilator. | 8 units | Class I | Ongoing | 20 Aug 2025 |
| Z-2229-2025 | DreamStation Auto. Non-Continuous Ventilator. | 28 units | Class I | Ongoing | 20 Aug 2025 |
Context
Other enforcement events for Philips Respironics, Inc.
All 26 events for Philips Respironics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Devices may possess a programming error resulting in an incorrect device configuration."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.