Philips Respironics PAP Recall
We are contacting all CPAP and BiPAP users after being notified of the Philips Respironics PAP machine recall, due to possible health risks related to the disintegration of a material inside the machine used to reduce noise. There may be small particles an/or gas produced by this material as it breaks down. There are concerns that it may increase the risk of cancer or cause airways (lung,sinus) disease. Please be aware that Ozone type CPAP cleaners increase the breakdown of this material, so DO NOT use those cleaners on your machine.
We are not aware of any evidence that this has occurred, but we share their concern and agree with their ultimate plan to provide patients with corrective measures. This is complex and confusing, and we suggest that if you have moderate to severe sleep apnea with underlying heart disease, history of stroke and/or significant high blood pressure, please call the office for an appointment (office visit or telemedicine) to determine the best plan with the least health risks for your specific condition.
Philips Recall Updates
09/01/2021 -FDA authorizes Philips PAP device repair program
On Sept. 1, Philips announced that it has received authorization from the Food and Drug Administration to “rework” the recalled first-generation DreamStation devices by replacing the sound abatement foam with a new material. Philips anticipates that the repair program will begin this month.
The company also confirmed that it already has begun replacing certain recalled devices with DreamStation 2 devices, which have a different, silicone-based foam that is not included in the recall. Philips indicates that it intends to complete the repair and replacement programs within approximately 12 months.
For more information, contact Philips at (877) 907-7508.
Frequently Asked Questions:
What CPAP Machines are under Recall?
On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021.
Current models under recall:
- SystemOne (Q series)
- DreamStation GO CPAP, APAP
- REMStar SE Auto CPAP
- Dream Station CPAP, Auto CPAP, BiPAP
- Dorma 400, 500 CPAP
Can I get a new machine through The Sleep Lab?
Unfortunately, we are unable to provide new machines at this time. We are happy to send a prescription to a local DME company for replacement. However, we are unable to guarantee insurance coverage or determine out of pocket expense(s) you may be responsible for.
If you have not done so, please register your device with Respironics.
To start the registration process, you may call Respironics at: 1-877-907-7508 , OR visit their website: www.philips.com/src
Please have your PAP machine serial number available, as this is needed to complete the registration process. You can locate your serial number on the bottom of your pap machine.
What should I look out for?
Please watch out for the following:
Black particles located in your mask, tubing, tubing port and/or filters, or any abnormal smells/fumes coming out of your machine. If you have developed worsening nasal congestion, headaches, coughing, wheezing etc.. since starting PAP therapy please contact our office to schedule an appointment with your provider.
Continue to wipe down your unit as advised and use mildy warm soapy water when washing your mask, tubing and headgear. Please be aware that Ozone type CPAP cleaners can increase the breakdown of this material, so DO NOT use those cleaners on your machine.
Should I stop CPAP therapy now?
If you have been told that you have moderate to severe sleep apnea OR you have a history of symptomatic obstructive sleep apnea, or histories that include: heart disease, heart attacks, or strokes, please consult your provider prior to discontinuing PAP therapy, as this MAY BE a bigger health risk at this time.
Are there any temporary or stop gap remedies right now?
Unfortunately, there are no quick fix remedies suggested by the manufacturer and this time.