The move comes as Philips has agreed to a consent decree with the Food and Drug Administration and the Department of Justice that could cost the company nearly $400 million.
In June 2021, Philips recalled certain breathing devices made between 2009 and April 26, 2021, and some ventilators distributed from April 15, 2021, to May 24, 2021.
“The polyester-based polyurethane foam used in these devices to reduce sound and vibration can break down,” the FDA wrote on its recall page.
“If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device,” the notice continued.
The FDA said inhaling or swallowing pieces of the foam could cause irritation to the skin, eyes, nose and respiratory tract; headaches; asthma and toxicity of the kidneys and liver.
Inhaling chemicals released into the device’s air tubes from the foam could spur headaches, dizziness, irritation, an allergic or other immune system reaction, nausea, vomiting and cancerous concerns.
As part of the tentative agreement, which still has to be approved by a judge, Philips would still service machines it’s already sold in the US, but couldn’t sell new ones until it makes the changes required by the FDA.
In Monday’s 2023 performance statement, Philips said it set aside about $393 million for “remediation activities, inventory write-downs and onerous contract provisions.”
The company vows to put “safety and quality at the center of everything we do with a greater level of accountability,” Philips CEO Roy Jakobs told analysts and investors.
The FDA told media outlets it cannot comment on Philips’ announcement until a final agreement is “signed and filed with the court.”
Most of the 5 million recalled devices are CPAP machines, which keep airways open by providing constant air pressure through a mask.
675 personal injury lawsuits have been filed against Philips over the recalled devices, with customers reporting delays in trying to obtain refunds or new or refurbished machines.
Sleep apnea occurs when breathing stops and starts many times during slumber.
Approximately 39 million American adults have obstructive sleep apnea, the National Council on Aging reports.
With Post wires