Important Notice: Voluntary recall by Philips Respironics for certain PAP devices
This notice from PRIME PULMONARY & SLEEP CENTER 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:
- skin or eye irritation
- irritation of the airway
- nausea or vomiting
- carcinogenic effects
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 WEBSITE for current information.
- CLICK HERE to look up your device serial number (located on the bottom of your device) and proceed with registering your device if it is affected.
- Call Philips at 877-907-7508 if you have questions about your device.
- Philips also advises you to AVOID USING OZONE PRODUCTS (such as the SOCLEAN machine) 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 UNTIL you talk to your medical provider to discuss your options.
- If your recalled device is a CPAP or BIPAP device for Sleep Apnea - Philips advises you to STOP using the device and contact your doctor or device provider.
- The American Academy of Sleep Medicine advises you to contact your medical provider as soon as possible. Your medical provider can help you determine if you should continue or discontinue treatment. Your provider may prescribe a new PAP device for you. Your provider also may discuss other treatment options with you.
- Please contact our office – PRIME PULMONARY & SLEEP CENTER at 661-695-6777 for more information about this notice or to schedule an appointment to discuss your treatment options.