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In response to the recall, the FDA conducted an inspection of a Philips Respironics’ manufacturing facility to determine what may have caused or contributed to the foam issues.ĭuring the manufacturing facility inspection, the FDA obtained additional information, not previously available to the agency, regarding the silicone-based foam used in a singular, similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Information Obtained During the 2021 Inspection FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (November 2021).
PHILIPS RECALLS SLEEP APNEA MACHINES HOW TO
How to Report a Health Issue or Problem with Your Device.What Philips Respironics is Required to Do.What to Do with Your Device: Cleaners, Filters, Foam, Returns.How to Know if You Should Stop Using Your Device.How to Tell if Your Device Has Been Recalled and What to Do Next.Repairing and Replacing the Recalled Devices.Information Obtained During the 2021 Inspection.The FDA developed this page to address questions about this recall and provide additional resources with more information. FDA inspections are designed to include the review and evaluation of records, staff training, facility operations, medical device production and testing, and the systems in place to ensure product quality. In response to the recall, the FDA recently conducted an inspection of a Philips Respironics’ manufacturing facility to determine what may have caused or contributed to the foam issues and assess adherence to the agency’s quality system regulations. Additionally, the foam damage may get worse in hot and humid settings and by using ozone or ultraviolet (UV) light cleaners or other cleaning methods not recommended by the manufacturer. These issues could potentially result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent injury to users. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. The polyester-based polyurethane foam used in these medical devices to lessen sound and vibration can break down. In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks.