Please contact your Philips Service representative, or Philips Customer Care Solutions Center at 1-800-722-9377 with questions. Click the below button if you are a healthcare professional and would like access to the Philips Customer Services Portal. Click the below button if you are looking for support for your consumer product.
While our patients are registering their devices, Philips is working to release replacement product and repair kits within each country and begin remediation. After your affected device has been registered, Philips will confirm your information and work to provide a replacement device.
For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Call 877-907-7508 if you cannot visit the website or do not have internet access.
Philips may provide a repair kit for select devices to select customers in lieu of a replacement device; for these select customers, Philips will compensate a fair market value for labor incurred involved in the repair process; in this case, advanced exchange is also no longer applicable.
Philips recalled their CPAP, BiPAP and ventilator devices in June 2021 because of potential health risks. The health risks come from sound abatement foam used to keep the machines quiet and reduce vibration. In July 2021, the FDA classified the Philips CPAP recall as a Class I recall.
Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks.
The best way to know if your device is included in the recall is to register your machine for the recall. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number.
The FDA reviewed and concurred with Philips' Respironics plan for recalled DreamStation CPAP and BiPAP machines, specifically DreamStation CPAP; Pro, Auto (All Configurations), Dream Station BiPAP; Pro, Auto (All Configurations) and DreamStation ST, ASV, AVAPS (All Configurations).
Date Issued: 11/12/2021 The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines.
All patients using affected CPAP/BiPAP devices are advised by Philips to discontinue use of the device but also consult with their doctor about the recommendation to stop using the device, because risks of stopping use of the device could outweigh the risks of the recall.
If you're using one of the machines that has been recalled by the FDA, you might think that you need to immediately stop using it, but that might not be helpful for your sleep apnea. As advised by the FDA, you shouldn't stop using your CPAP device just because it's listed in the recall.
around $100,000 to $500,000Some attorneys speculate that victims of illnesses resulting from the use of recalled Philips continuous positive airway pressure (CPAP) machines may reach settlement amounts of around $100,000 to $500,000, but it's still unknown exactly how much these settlements will be worth.
To begin a claim for repair or replacement of your device fill out the form at https://www.philipssrcupdate.expertinquiry.com/ or call Philips at 877-907-7508.
Potential risks include headache and respiratory problems. The foam also may off-gas certain chemicals. Philips indicates that this foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments also may contribute to foam degradation.
Dr. Akinyemi Ajayi said the delay is in part because of supply chain issues. But like the baby formula shortage, he said a recall issued last year is the biggest issue. “There was a recall of CPAP machines from one of the biggest manufacturers of CPAP machines, Philips Respironics,” Ajayi said.
For patients using life-sustaining mechanical ventilator devices, we recommend patients do not stop or alter prescribed therapy until after talking with your ordering provider.
Please contact your Philips Service representative, or Philips Customer Care Solutions Center at. 1-800-722-9377 with questions. Click here to see 2021 US holiday schedule.
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Call 877-907-7508 if you cannot visit the website or do not have internet access.
As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.