Philips Respironics has issued another ventilator recall deemed the most serious type by the FDA as it may cause serious injury or death.
It marks the latest recall development for the Respironics business at the Dutch medtech giant. For years, the unit grappled with a significant respiratory device recall that knocked it out of the market at one point.
The FDA issued a notice to warn of the latest recall, initiated by Philips through an urgent medical device recall letter in June. Philips told customers to continue using their affected devices — certain DreamStation Auto continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) systems — until the company delivers a replacement. These are different devices than the DreamStation Go systems the company pulled from the market last year.
According to the FDA, it identified the recall as the most serious type, as Philips reports three injuries and no deaths related to the issue. This notification regard 93 specific units, with 65 in the U.S. and 28 in France. Affected devices can remain in use until replacement. The FDA communication was a re-issuance of a prior notice from October 2023, not a new action.
DreamStation Auto devices offer nightly use at home or in clinical settings to treat obstructive sleep apnea. Affected devices were reworked as part of the company’s earlier foam-related remediation effort, but may have been incorrectly configured before distribution, according to the FDA notice.
Philips identified a programming error introduced during rework by a supplier. This error can result in incorrect therapy modes, such as BiPAP configured as CPAP, limited pressure, unavailable features or improper sensor/humidifier function. Using affected devices can cause serious health consequences. Those include hypoventilation, disrupted sleep, skin or airway burns, and ineffective treatment of sleep apnea which could worsen comorbidities.
Statement from Philips
A statement was shared with MassDevice via email by a Philips spokesperson:
Philips Respironics has intensified efforts to strengthen patient safety and quality across the company. We are methodically working through product quality at all levels and businesses in a multi-year program. We act fast on post market surveillance signals, proactively issuing corrections, updates or recalls when we identify potential issues.
In July 2025, the company issued a notice to customers of certain DreamStation Auto CPAP and DreamStation Auto BiPAP devices. This affects approximately 93 units total, in the U.S. (65) and France (28).
The July 2025 customer notice is a re-issuance of a similar product notification from October 2023 to those customers who had not yet responded by phone to the prior customer outreach. Philips Respironics continues to send replacement devices to customers as needed, as well as recover affected units.
The updated notice indicates that a limited number of devices exhibited a testing error and may have been programed with an incorrect device configuration while being remediated by a Philips supplier.
At the time of this notification, Philips Respironics has not received any reports of serious patient harm due to this issue. Until replaced, affected devices may continue to be used in accordance with their Instructions for Use (IFU) and the guidance in the notice.
Affected device models include:
| Product Description | Model Number | UDI-DI |
|---|---|---|
| DreamStation Auto CPAP | UDSX500S11F | 00606959423314 |
| DreamStation Auto BiPAP | UDSX700S11F | 00606959423338 |
| DreamStation Auto CPAP | UFRX500S14 | 00606959455045 |
