URGENT medical device recall:
Philips Respironics is voluntarily recalling some CPAP and Bi-Level PAP Devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation. Read the notice to find out more info and see if you device is affected.
lastest update
We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. While Philips works to provide our patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. Their new website will provide more up to date info, make sure if you haven't already, to register your device. Philips has added a prioritization process to ensure patients with the greatest needs receive a replacement device as timely as possible, they will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. The data collected will be used to help to prioritize remediation of those patients at higher risk.
Once you've registered your device, please remember to save your confirmation number which will be emailed to you and the zip code you used to register.
From the The U.S. Food and Drug Administration (FDA) was posted on June 30th, 2021
More information is emerging about Philips' recall , here is the new safety communication from the FDA
Notice of recall
This communication is to inform you of the Philips Respironics voluntary manufacturer recall. We are learning about this manufacturer recall in real time, with our patients, through the news and media. The manufacturer of the Dreamstation, SystemOne, and REMstar SE Auto did a voluntary recall, on June 14th, they announced a recall notification (U.S. only) / field safety notice (Outside of U.S.) for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. The current guidance from the manufacturer is that patients stop using their machine immediately and consult with your ordering physician about alternative therapies or continued use. You can verify your affected device by clicking the link and entering your serial number at philips.com/src-update or call 1-877-907-7508 for more information.
Fairway Medical was officially notified by mail a few days ago, the notice contained very few details. What we have learned, it affects close to 4,000,000 PAP devices in the USA. Philips Respironics has not provided us a timeline on the replacement or repair of the affected devices. In addition, the worldwide pandemic has created additional stress to the existing PAP device supply chain.
We realize this is unwelcome news, but please be assured that our primary focus is on your safety and health. Exceptional patient care has always been our focus at Fairway Medical. The recall has affected most of our current inventory, so we simply can't replace your device with another one. We understand your therapy is important to you. We are in the health-care business and will work tirelessly to fulfil that commitment and continue serving you, the best we can.
Fairway Medical strongly recommends all patients impacted by this recall consult with their medical doctor/clinician responsible for prescribing their cpap, bipap for clinical direction on the further use or discontinuation of your medical equipment.
Fairway Medical was officially notified by mail a few days ago, the notice contained very few details. What we have learned, it affects close to 4,000,000 PAP devices in the USA. Philips Respironics has not provided us a timeline on the replacement or repair of the affected devices. In addition, the worldwide pandemic has created additional stress to the existing PAP device supply chain.
We realize this is unwelcome news, but please be assured that our primary focus is on your safety and health. Exceptional patient care has always been our focus at Fairway Medical. The recall has affected most of our current inventory, so we simply can't replace your device with another one. We understand your therapy is important to you. We are in the health-care business and will work tirelessly to fulfil that commitment and continue serving you, the best we can.
Fairway Medical strongly recommends all patients impacted by this recall consult with their medical doctor/clinician responsible for prescribing their cpap, bipap for clinical direction on the further use or discontinuation of your medical equipment.
For patients on Bi-level PAP and CPAP devices we would recommend that they not stop their prescribed therapy until first discussing with their physician
- severe breathing difficulties
- were very sleepy during the daytime before treatment
- have significant pulmonary cardiovascular or neurologic comorbidity
- who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators)
next steps for our patients affected by the recall
- If you are a current supply patient who owns their device, please register your device on the philips.com/src-update. They will handle all the replacement / repair processes. We are working with Philips Respironics and will continue to communicate information to you, as we learn more.
- If we are currently billing your insurance for your PAP device, Fairway Medical will handle the recall process. We are working with Philips Respironics and will continue to communicate information to you, as we learn more. Please fill out this form below so we can come up with the best solution possible. START FORM