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Respiratory Devices

All articles tagged with #respiratory devices

health-business1 year ago

"Philips Halts US Sales of Sleep Apnea Machines Due to Safety Concerns and Recalls"

Philips is stopping sales of its recalled sleep apnea machines in the US due to foam particles being released into users' airways, leading to potential health risks. The company has reached a consent decree with the Department of Justice and FDA and will not sell new CPAP or BiPAP devices in the US until meeting FDA requirements. Philips has set aside €363 million to address the FDA's requirements and will continue to provide service to sleep and respiratory devices in the US while also selling the machines outside of the US.

via The Verge|
#fda#health-business#philips
health1 year ago

"Philips Halts Sales of Sleep Apnea Machines in US Amid Safety Concerns"

Philips, the company behind a global recall of sleep apnea machines, has agreed to stop selling the devices in the U.S. due to risks associated with their internal foam breaking down over time. The tentative agreement with regulators could cost the manufacturer nearly $400 million, and Philips has agreed to a consent decree with the FDA and the Department of Justice. The company will continue servicing previously sold machines in the U.S. but cannot sell new ones until it meets corrective actions laid out by the FDA. The recall affects over 5 million pressurized breathing machines, and the company faces personal injury lawsuits related to the devices.

via HuffPost|
#fda#health#philips
health-business1 year ago

"Philips Ceases US Sales of Sleep Apnea Devices Amid Recall Crisis and FDA Deal"

Philips Respironics has agreed to stop selling sleep apnea machines and other respiratory devices in the United States following a catastrophic recall due to potentially toxic particles and fumes being released into the masks worn by patients. The settlement with the federal government will all but end the company’s reign as one of the top makers of breathing machines in the country, and it could be years before they can resume sales. The halt in sales will impact patients and doctors, and the company's stock prices plunged by 7% after the announcement. The settlement comes after relentless criticism about the safety of the machines and calls for a criminal probe of Philips by federal lawmakers.

via ProPublica|
#health-business#philips#recall
business2 years ago

Philips' Q1 Earnings Beat Expectations Despite Recall Provision and Litigation Costs

Dutch health technology company Philips reported better than expected Q1 results, with a 50% jump in core profit and 6% growth in comparable sales. The company also set aside €575m for litigation costs related to the recall of respiratory devices, which has caused a 70% drop in its market value since June 2021. Philips still needs to reach a settlement with the US Food and Drug Administration and is facing lawsuits from individual patients. While analysts see this as a positive update, they warn that litigation impact and market uncertainty remain.

via Reuters.com|
#business#litigation-costs#philips