Philips Respironics announced a voluntary 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: 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 initial operation and may possibly continue throughout the device’s useful life.
In November 2021, following further assessment of the issue, and discussions with regulatory agencies, Philips updated its recall notification. This update provides patients with information on broader guidance regarding clinical use of affected devices, following consultation with their physicians.
For a list of all affected products, please visit our main recall notification (U.S. only) / field safety notice (Outside of U.S.) page.
Philips is working tirelessly to remedy this issue by replacing the affected devices. A recall notification (U.S. only) / field safety notice (Outside of U.S.) with immediate actions to be taken has been sent to distributors and institutions that are a direct customer of Philips for their own use as well as for engagement with patients.
At this time, Philips is producing repair kits and replacement devices in large quantities. We have increased the production capacity of repair kits and replacement devices in the third quarter of 2021 to 55,000 per week and we aim to further increase that capacity to 80,000 units per week in the fourth quarter of 2021. As our production capacity is fully focused on the repair and replacement actions, we are currently not taking orders for sleep therapy devices for new patients.
Your patients are likely to contact you for guidance and we are committed to providing you with information and tools to have an informed discussion with them and make your clinical recommendation. Please view the Q&A’s below and download the Clinical Information PDF here.
For the past 40 years we have centered our business around our commitment to patient care, with solutions that are aimed at improving the lives of people with respiratory and sleep challenges. We recognize the importance of providing safe and effective therapy.
We are committed to holding ourselves to the highest standards of product quality and safety in an effort to do what is right for you, and the patients who trust you with their care.
We are committed to resolving this issue and providing transparent, ongoing communication as we navigate the next steps.
We are committed to providing you information and resources for your own understanding, but also to help you communicate with your patients effectively and efficiently.
For other inquiries or to speak with a support specialist, you can also call 877-907-7508.
We sincerely apologize for this disruption. We are fully committed to supporting you and your patients throughout this process.