Philips removes certain DreamStation devices 

WASHINGTON – Philips Respironics has removed certain DreamStation devices due to programming errors that can result in failed therapy modes, according to the U.S. Food and Drug Administration. 

The affected devices are: 

• DreamStation Auto CPAP UDSX500S11F 00606959423314 
• DreamStation Auto BiPAP UDSX700S11F 00606959423338 
• DreamStation Auto CPAP UFRX500S14 00606959455045 

Reason for recall 

Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier, which may result in incorrect therapy modes (e.g., BiPAP configured as CPAP), limited pressure, unavailable features or improper sensor/humidifier function. 

Use of the affected devices may cause serious health consequences, including hypoventilation, disrupted sleep, skin or airway burns and ineffective treatment of sleep apnea, which could worsen comorbidities. 

There have been three reported injuries and no reports of death, according to the FDA. 

What to do 

• Continue using the device until a replacement is delivered. 
• Contact Philips at 1-877-387-3311 or PatientSupport@philips.com. 
• Return affected devices using the included instructions and prepaid label when the replacement arrives. 
• Be aware that Philips is calling affected patients and suppliers and sending replacement devices with return instructions. 

Response from Philips

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.