DreamStation CPAP Recall Issued by Philips Over Injuries Linked to Software Problem

Recent recall may stem from flawed configuration changes made during earlier efforts to fix PE-PUR foam issues, which led to a $1.1 billion Philips CPAP settlement last year.

Philips Respironics has issued a new recall affecting select DreamStation ventilators, citing software issues that may have resulted from prior configuration changes made during remediation of PE-PUR foam defects, which has already resulted in a $1.1 billion settlement for former users of the devices.

The U.S. Food and Drug Administration (FDA) announced the Philips DreamStation ventilator recall on September 12, warning that software errors may result in improper oxygen delivery and disrupted sleep apnea therapy, potentially increasing health risks for patients with preexisting conditions.

DreamStation ventilators are a type of CPAP or BiPAP device, which are used to treat obstructive sleep apnea, a condition where an individual’s airway repeatedly collapses during sleep, leading to pauses in the person’s breathing. Untreated sleep apnea can cause multiple complications, including high blood pressure, heart disease, stroke, type 2 diabetes and other cognitive problems.

CPAP and BiPAP devices treat sleep apnea by providing oxygen flows to keep a person’s airways open during rest, through a mask and hose connected to the machine, which blows air into the airway to help prevent the throat from collapsing.

When one of these devices stops working properly, as in the case of the current DreamStation recall, it can lead to hypoventilation, disrupted sleep, skin or airway burns, and other ineffective sleep apnea treatments for the user. 

According to the FDA recall notice, there have been at least three reported injuries as a result of the current Philips ventilator device issue.

The FDA is warning users that certain Philips DreamStation Auto CPAP and Auto BiPAP machines may have a programming error, which could result in incorrect therapy modes, such as BiPAP machines being configured as CPAP machines, limited pressure, unavailable features, or improper sensor functions, which can potentially worsen a person’s sleep apnea comorbidities.

The following model numbers and unique device identifiers (UDIs) are affected, which are used both at home and in clinical settings:

• DreamStation Auto CPAP, model number UDSX500S11F and UDI 00606959423314
• DreamStation Auto BiPAP, model number UDSX700S11F and UDI 00606959423338
• DreamStation Auto CPAP, model number UFRX500S14 and UDI 00606959455045

According to a Philips Respironics recall letter sent to affected customers on June 6, 2025, the devices should continue to be used until a replacement arrives, at which time, they should be returned to Philips, using the included instructions and prepaid label.

Customers who have received a recall notice but have not heard from Philips or who have additional questions can contact the company by phone at 1-877-387-3311 or via email at PatientSupport@philips.com.

The FDA may also be contacted at the agency’s Safety Information and Adverse Event Reporting Program, MedWatch.

Philips Ventilator Settlement

According to the manufacturer, the current Philips ventilator recall may have been the result of incorrect configuration solutions from an earlier foam-related remediation effort.

In June 2021, Philips recalled more than 15 million CPAP, BiPAP and mechanical ventilators after discovering that a foam component used to reduce noise could break down and release toxic particles and chemicals into the patient’s airways.

The degraded foam was linked to serious health risks, including cancer, respiratory complications and organ damage, with patients reporting lung disease, chronic bronchitis, kidney and liver injuries, heart attacks, and strokes. As thousands of users reported side effects, federal regulators advised users to stop using the machines immediately, unless they were essential for life-sustaining therapy.

The recall prompted tens of thousands of Philips CPAP lawsuits nationwide, with each complaint alleging that the company knowingly sold defective devices for years without adequate warnings. Plaintiffs brought claims for personal injuries, wrongful death, and sought compensation for medical monitoring and reimbursement for replacement equipment.

In April 2024, following mediation led by Judge Diane M. Welsh, Philips Respironics agreed to pay $1.1 billion to resolve the bulk of those injury and monitoring claims. The settlement, revealed in the company’s first-quarter investor report, ranks among the largest mass tort agreements in recent history. While Philips did not admit any wrongdoing, payments are expected to begin this year, with approximately $40 million covered by insurance.

This resolution came shortly after U.S. District Judge Joy Flowers Conti approved a separate $479 million class action settlement intended to compensate users who purchased, rented or leased the recalled machines. An additional $34 million was allocated to insurers and other third parties that had covered the cost of replacements. That agreement did not include personal injury claims, which were instead addressed by the larger $1.1 billion settlement.

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