MedWatch - The FDA Safety Information and Adverse Event Reporting Program Today, the U.S. Food and Drug Administration (FDA) 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. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc. and the American Academy of Sleep Medicine, and has included this feedback in the updated "Frequently Asked Questions" to provide helpful information to the public. Questions? For more information on the recall notification, contact your local Philips representative or visit Philips Respironics' recall notification page. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. |
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