All articles tagged with #philips respironics
The future of Philips Respironics, a significant contributor to Western Pennsylvania's economy, is uncertain, raising questions about its impact on the region. The company, which specializes in sleep apnea and respiratory care products, has faced challenges such as product recalls and regulatory issues, leading to speculation about potential changes in ownership or operations.
The FDA has linked 561 deaths to the recalled Philips Respironics breathing assistance devices due to the breakdown of polyester-based polyurethane foam used in the machines, leading to health injuries. More than 116,000 reports, including the 561 deaths, have been associated with the foam breakdown. Philips has stopped selling breathing machines in the U.S. until it meets conditions laid out in its settlement with the FDA, which could take at least a year, and has agreed to pay nearly $480 million to affected users while facing numerous lawsuits.
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.
Philips Respironics' recall of its DreamStation breathing machines and other sleep apnea devices has left millions of patients waiting for replacements due to foam inside the machines potentially releasing carcinogenic materials. A documentary film captures the experiences of patients and doctors navigating the fallout of the recall, highlighting the difficult choices faced by patients and the impact on their lives. The film aims to humanize the individuals affected and raise awareness about the implications of the recall.
An investigation has revealed that Philips Respironics, a manufacturer of CPAP machines used to treat sleep-related breathing disorders, including sleep apnea, concealed safety issues with its devices for years. The company made a critical change to millions of its breathing machines, leading to concerns about potential health risks for the approximately 8 million Americans who rely on these devices.
Senator Richard Blumenthal is urging the Department of Justice to take action against Philips Respironics after it was revealed that the company withheld over 3,700 complaints about faulty breathing machines for 11 years before issuing a recall in 2021. The machines, used by infants, the elderly, COVID-19 patients, and veterans, were found to release hazardous particles and fumes. The FDA has criticized the safety tests conducted by Philips and stock prices for the company's parent company, Royal Philips, fell by over 9% after the FDA's announcement. Blumenthal and other lawmakers are calling for immediate action to hold Philips accountable for its actions.
The U.S. Food and Drug Administration has issued a new alert about Philips Respironics' continuous positive airway pressure (CPAP) machines, which were recalled in June 2021 due to foam inside the units breaking off and blowing into users' mouths. The repaired machines have also been recalled, as they were given the wrong or a duplicate serial number when Philips re-programmed them. The error can cause the devices to deliver the wrong prescription to sleep apnea patients, or fail to offer any therapeutic benefits, which could lead to respiratory failure or heart failure. Philips has received 43 complaints about the reworked machines, although no injuries or deaths have been reported.