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Fda Settlement

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"Philips Faces Setbacks and Progress in CPAP Machine Recall and Rebuilding Efforts"

Originally Published 1 year ago — by The Washington Post

Philips Respironics will stop U.S. sales of its ventilators and CPAP breathing machines after reaching a settlement with the FDA, following a recall of over 1 million machines in 2021 due to reports of blowing gas and foam into users’ airways. The company will continue servicing existing machines but halt new sales until certain conditions are met, with a settlement amount yet to be determined. The sales halt affects widely used CPAP and BiPAP machines, and the company has apologized for the harm caused to patients, while the FDA remains unsatisfied with the recall's status as of October.

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"Philips Halts U.S. CPAP Sales Amid Recall Crisis and FDA Deal"

Originally Published 1 year ago — by The New York Times

Philips Respironics has suspended sales of all its breathing machines in the United States following a settlement with the FDA over ongoing issues with the devices, including reports of foam and potentially toxic gases being released into consumers' airways. The company must meet a list of standards in a "multiyear" plan before it can resume business in the U.S. and will continue to repair existing devices. The FDA has pushed back on some of the company's updated claims and the agreement is pending finalization and filing with the court.

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