Respironics has issued a general recall of the Dreamstation 1 AutoPAP, BIPAP and ASV machines.
THE WEBSITE TO REGISTER YOUR DEVICE FOR RECALL IS http://www.philips.com/src-update
On June 14, 2021, Philips issued a recall notice for some of their Dreamstation positive airway pressure (PAP) devices due to potential health risks from the polyester-based polyurethane foam used in their devices. Specifically, the foam may degrade into particles that may be inhaled by the user. Reportedly, degradation may be worsened by unapproved cleaning methods (e.g. ozone). According to Philips, this issue has affected 0.03% of patients on their CPAP machines.
The exact risks are unclear, but we hope that more information may be available in the near future. The potential risks of degraded foam exposure are listed on the manufacturer’s website .
- Short term: Cough, shortness of breath, nasal secretion, chest pain, and sinus headaches.
- Long term: Unknown, although foam is noted to off-gas a chemical that may cause long term toxicity.
Thus far, this has been a voluntary recall and applies ONLY to the US and Canada. These devices have not been recalled in Europe or elsewhere.
Philips has not given any indication on the magnitude or certainty of the risks. Without this crucial data, it is impossible to quantify risk of past or ongoing use.
All patients with a recalled device should be receiving a letter or contact in the next few weeks with detailed information about the recall.
Recommendations for patients: (based on current recommendations from the American Thoracic Society and American Academy of Sleep Medicine) Recommendations may change as we review and obtain more information
Register your device for the recall as soon as possible at:
- STOP using any ozone-based CPAP cleaner. This includes the SoClean device, among others.
- If you have access to an older model 60 series device, Dreamstation 2 device or Resmed device, please contact us and we will set this device to your current pressure settings. These devices are not affected by the recall.
- If you are using life-sustaining mechanical ventilator devices, we would recommend that you do not stop or alter prescribed therapy until after talking to your sleep medicine provider
- If you work in a safety-critical position (such as professional drivers, pilots, heavy equipment operators), we would recommend that you not stop your prescribed therapy until first discussing with your sleep medicine provider.
- If you have severe sleep apnea, severe breathing difficulties, or were very sleepy during the daytime before treatment, have significant lung disease, heart disease or neurologic conditions we would recommend that you not stop your prescribed therapy until first discussing with your sleep medicine provider.
- If you have mild – moderate sleep apnea without excessive daytime sleepiness and no other cardiac or respiratory conditions as above, then we recommend that you stop using your machine until you receive a replacement device
If you wish to discuss your personal health risks in more detail, please schedule a brief, 10-minute review of your personal history and next steps in your care with one of our sleep medicine providers. Alternatively, you may schedule a follow up appointment with your sleep medicine provider to discuss the risks and benefits as well as alternative treatment options.
We know that this process has been confusing and frustrating for our patients, especially as the recommendations may change day by day. We are committed to assisting you as best we can to ensure that you have the healthiest sleep possible.
Pacific Sleep Program
Click here for Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
Click here for SRC Update: Main recall page
Click here for Actual Recall Notice
Click here for Information for Physicians & Providers
Click here for FAQ for physicians and providers
Click here for the affected products
Click here for General Recall Q&A
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