After a catastrophic recall, Philips Respironics said it will stop selling sleep apnea machines and other respiratory devices in the United States under a settlement and consent decree with the FDA that will all but end the company’s reign as one of the top makers of breathing machines in the country. Via Pittsburgh Post-Gazette:
The agreement, announced by Philips early Monday, comes more than two years after the company pulled millions of its popular breathing devices off the shelves after admitting that an industrial foam fitted in the machines to reduce noise could break apart and release potentially toxic particles and fumes into the masks worn by patients.
It could be years before Philips can resume sales of the devices, made in two factories in Murrysville and New Kensington. The company said all the conditions of the multiyear consent decree — negotiated in the wake of the recall with the Department of Justice on behalf of the Food and Drug Administration — must be met first.
The move by a company that aggressively promoted its machines in ad campaigns and health conferences — in one case with the help of an Elvis impersonator — follows relentless criticism about the safety of the machines.
Phillips was already dealing with recall two years ago, and replaced their defective units with… a new one that possibly leaks formaldehyde!
A Pittsburgh Post-Gazette and ProPublica investigation found the company held back thousands of complaints about the crumbling foam for more than a decade before warning customers about the dangers. Those using the machines included some of the most fragile people in the country, including infants, the elderly, veterans and patients with chronic conditions.
Philips sold 37% of CPAP machines in the U.S.