Today, the U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines.
“Ensuring patients and providers have the most up-to-date information regarding the recall of these critical devices is a top priority for the FDA,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We recognize that patients rely on these devices, and we are closely monitoring the company’s actions to ensure that the issues are resolved in a timely manner given the impact on patients. We are committed to continuing to regularly update the public about the status of this recall, including any new recommendations or actions regarding Philips Respironics’ devices.”
Earlier this year, Philips Respironics initiated a recall of certain ventilators, CPAP and BiPAP machines due to potential health risks related to polyester-based polyurethane sound abatement foam used in the devices. This particular foam may break down and can result in serious injury, which can be life-threatening, cause permanent impairment and require medical intervention to prevent permanent injury to users.
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...
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