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Update on Philips Respironics June 2021 Recall Today, the FDA's Center for Devices and Radiological Health (CDRH) is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics ("Philips") to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). This proposal is in addition to the FDA's previous action under section 518(a) to require Philips to provide notification to customers of the recall and the health risks presented by the recalled devices. We will continue to update the public about the status of this recall and share more information when it becomes available. "CDRH is proposing an important step in its continuing efforts to address the impact of the recall on patients. We will take appropriate actions and use the tools available to us to help assure patients receive the relief they need." — Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. 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 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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