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Important Notice: Voluntary recall by Philips for certain PAP devices

 

This notice from SleepMS|Dr. Alex Clerk’s Office contains an important health and safety update. Please read this notice in its entirety.

 

Philips has issued a voluntary recall for specific Philips Respironics CPAP, bilevel PAP, and mechanical ventilator devices. The recalled machines include the DreamStation devices that are used to treat obstructive sleep apnea. (The newer DreamStation 2 is not affected.) Philips has begun a process to repair and replace affected devices. How long this process will take is unclear.

 

The recall is related to the type of foam used to reduce the noise made by the devices. Over time, the foam inside the machine may fall apart into black particles. These particles can enter the humidifier,

tubing and mask. As a result, you may inhale the particles when using the device. Testing by Philips also found that the foam can produce unsafe chemical levels. These “volatile organic compounds” are released as gases.

 

Philips reports that the potential risks to you include:

  • headache

  • skin or eye irritation

  • asthma

  • irritation of the airway

  • nausea or vomiting

 

Philips reports that in 2020 the complaint rate for foam particles was low (0.03%). To date, there have been no reports of death. Philips has received no complaints related to chemical exposure.

 

What should you do if you use a Philips PAP device?

  • Visit the Philips recall webpage for current information.

  • Use the Philips registration process to look up your device serial number. Further assistance to locate your serial number can be found here.

  • Begin a claim with Philips if your unit is affected.

  • Call Philips at 877-907-7508 if you have questions about your device.

  • Philips also advises you to avoid using ozone products to clean your PAP device. Philips reports that ozone-related cleaners may help wear down the foam in the device.

  • If your recalled device is a life-sustaining mechanical ventilator:

    • DO NOT stop using the device.

    • Talk to your medical provider to discuss your options.

  • If your recalled device is a CPAP or BPAP device for sleep apnea:

    • Philips advises you to stop using the device and contact your doctor or device provider.

    • A prescription for a new PAP device by a different manufacturer is enclosed.

    • Please contact your current DME provider to fill this prescription.

 

Please contact SleepMS|Dr. Alex Clerk’s Office at admin@sleepmsinc.com, (408) 295-4532 or by using our Patient Portal for more information about this notice or to discuss your treatment options.

Philips Respironics

Recall Registration Demo

Frequently Asked Questions

What Happened? 

 

On Monday, June 14th, Philips Respironics issued a voluntary recall on nearly all of their CPAP, APAP, and BiPAP machines sold from 2009 until today, with some exceptions. 

Per Philips Respironics CEO Frans van Houten “We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety.” 

Per the Philips Respironics recall notice:

“We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain, and other functions to support the correction.

We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.”

 

Why Did Philips Respironics Issue a Voluntary Recall?

 

Philips Respironics identified there is a risk the PE-SUR sound abatement foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.

 

What Is the Safety Hazard Associated With This Issue?