UNITED STATES – The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: Philips Respironics DreamStation1 (Uno Remediated Devices)
- Product Models: REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto CPAP, DOM – RECRT
- Serial Numbers: See Medical Device Recall Database
- Distribution Dates: December 1, 2021 to October 31, 2022
- Devices Recalled in the U.S.: 1,088
- Date Initiated by Firm: February 10, 2023
Note: This recall is for certain reworked DreamStations that were also recalled in June 2021.
Device Use
Philips Respironics (Philips) DreamStation devices help people with breathing conditions keep breathing at a regular rhythm. They are used both in hospitals and healthcare settings as well as by people in their homes. The DreamStation can provide both continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) support.
- A CPAP machine keeps your airway open by providing a stream of air at a continuous pressure through a mask. CPAP machines are often prescribed to people with obstructive sleep apnea to keep their airways open during sleep.
- A BiPAP machine pumps air under varying pressure into the airway of the lungs. BiPAP machines use a higher pressure when you breathe in and lower pressure when you breathe out. These devices are also prescribed to people with obstructive sleep apnea to keep their airways open during sleep.
Reason for Recall
Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed.
Incorrect therapy or therapy failure may lead several health conditions such as respiratory failure, heart failure, serious injury, and death.
Philips has received 43 complaints about this issue. There are currently no reported injuries or deaths.
Who May be Affected
- People who receive breathing support from the affected DreamStation machines.
- Health care providers and in-home caregivers who provide care for patients who use DreamStations for breathing support.
What to Do
On February 10, 2023, Philips sent affected customers and patients an Important Product Notice with the following recommendations:
How to identify affected products
- Locate the serial number of the device and verify it against the serial numbers noted in the letter.
For users and patients
- Continue to use the current device until a replacement device is received or until pressure changes are made by your provider on the current device.
- Contact your provider to ask about getting a manual reset of pressure either remotely or in person (fastest).
For customers
- Provide the enclosed letter to affected patients.
- Replacement product will be provided to customers for exchange of affected devices.
Philips is attempting to contact all users and/or patients by phone to set up pressure changes or replacement and return of affected devices.
Contact Information
For questions and support, contact Philips Respironics:
Customers
- Phone: 1-800-345-6443, prompts 4, 5
- Email: respironics.clinical@philips.com
Patients and Users
Contact your local Philips representative:
- Phone: 1-(877)-387-3311
- Email: patientsupport@philips.com
- Web: Philips Information for PatientsExternal Link Disclaimer
Additional Resources:
- Medical Device Recall Database Entry
- Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris
- FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.
