ALERT: Phillips Dream Station, System One, Dorma 400/500 and REMstar SE RECALL

Below is the link for American Academy of Sleep Medicine for further information regarding the recommendations for patients with Phillips Respironics CPAP and BiPAP machines.

The manufacturer has issued a recall and recommends that patients immediately STOP using the machine.

Click on the link for further information and/or contact the office to make an appointment to see the doctor for additional treatment options.

Continued use of these machines is against medical advice and at your own risk.

https://aasm.org/philips-dreamstation-cpap-recall-notification/

A Letter From Our Office

Dear Patients,

Philips Respironics has issued a voluntary recall notification for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. These devices are being recalled to address potential health risks related to the foam used to make the devices quieter.

This foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user. The foam may also emit certain chemicals as the foam degrades. The foam degradation may be made worse if one uses an unapproved cleaning method, such as ozone.

Philips advises the following actions:

  • Visit http://philips.com/src-update to view Philips’ responses to the situation and the instructions provided to patients and home care providers on replacing or repairing the devices.
    • All patients should register their device with Philips using the above link.
    • Patients should contact their DME supplier and/or health plan for additional guidance.
  • Understand potential risks of foam degradation and off-gassing which includes, but may not be limited to, headache/dizziness, irritation (skin, eye, nose, and respiratory tract), inflammatory response, asthma, hyper-sensitivity, nausea/vomiting, adverse effects to other organs (e.g. kidneys and liver), possible toxic and carcinogenic effects, and respiratory problems.
  • Explore alternative treatment options for your doctor.

Additional information from Philips:

Additional Informational from the Manufacturer:

Important Notice: Voluntary recall by Philips for certain PAP devices

This notice from issued by 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. Testing results suggest these emissions taper off during the initial days of use of a new device.

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.
  • 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:
    • The FDA advises you to talk to your health care provider to decide on a suitable treatment for your condition.
    • 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 the office at 610-383-6033 in order to make an appointment to see the Doctor to discuss your treatment options.

Updated 7/16/21

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