 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company's June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company's notification efforts to date have been inadequate. Ensuring patients and providers have important information regarding the recall of these critical devices is a top priority for the FDA. Taking this action enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company. Questions? The FDA.gov website includes Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions to address questions about the recalls and provide additional resources with more information. For more information on the company's 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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