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Class I Recall for Certain Reworked Philips Respironics DreamStation 1 CPAP and BiPAP Machines

Tuesday, May 2, 2023

In February 2023, Philips Respironics (Philips) recalled some reworked Philips DreamStation 1 continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. This recall is for DreamStation 1 CPAP and BIPAP devices reworked by Philips that were also recalled in June 2021. 

This is a Class I recall. Class I recalls are defined by the FDA as having “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” For specific recall details such as product models and serial numbers, refer to the FDA's website.

Health Net Federal Services, LLC (HNFS) recognizes you may still have patients who are waiting for a replacement machine from Philips. Philips continues to advise patients to visit www.philips.com/src-update or call 1-877-907-7508 to register recalled devices and get answers to frequently asked questions. Philips also encourages health care providers and patients to discuss patients’ next steps for treatment.   

For your TRICARE patients who choose to use their TRICARE benefit for a replacement CPAP or BiPAP machine, we offer the following reminders:    

  • TRICARE covers new, non-recalled devices when a medically necessary device has been recalled.
  • Patients using their TRICARE benefit will need a new prescription/certificate of medical necessity from their provider (or referral for durable medical equipment) to receive a new device.
  • Per TRICARE guidelines, providers also must submit an authorization request to HNFS for a replacement. Please indicate the request is for a recalled device.
  • Patients may need to pay appropriate copayments or cost-shares based on their TRICARE plan.
  • A new sleep study is NOT required to replace a recalled device.  

Find additional information on TRICARE coverage of CPAP machines and details about the recall on our Continuous Positive Airway Pressure (CPAP) Machine page. For the latest FDA guidance, visit the FDA's 2023 Medical Device Recall page.