"Philips Halts US Sales of Sleep Apnea Machines After FDA Links 561 Deaths to Recalled Devices"

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.