Philips announced Monday that it will stop selling its sleep apnea machines in the United States, more than two years after the Dutch manufacturer began recalling the ventilators due to potential health risks.
This movement looks like this Phillips agreed to a consent decree Negotiations with the Food and Drug Administration and the Department of Justice could cost the company nearly $400 million.
June 2021Philips has recalled certain respirators manufactured between 2009 and April 26, 2021, and some respirators distributed between April 15, 2021 and May 24, 2021. .
“The polyester-based polyurethane foam used in these devices to reduce sound and vibration can fail,” the FDA writes on the recall page.
“If this occurs, the person using the device may inhale or swallow black foam particles or certain invisible chemicals,” the notice continues.
The FDA said that inhaling or swallowing foam pieces can cause irritation to the skin, eyes, nose, and respiratory tract. Headache; asthma, kidney and liver toxicity.
Inhaling chemicals released from the foam into the device’s air tubes can cause headaches, dizziness, irritability, allergic or other immune system reactions, nausea, vomiting, and cancer concerns.
As part of the tentative agreement, which must be approved by a judge, Philips will continue servicing the machines it already sells in the United States, but cannot sell new machines until it makes changes required by the FDA.
In its 2023 earnings report on Monday, Phillips said it had set aside approximately $393 million for “remediation activities, inventory write-downs, and onerous contractual provisions.”
Philips CEO Roy Jacobs vowed to analysts and investors that the company would “place safety and quality at the center of everything we do, with a higher level of accountability.” ing.
The FDA told the media it could not comment on Phillips’ announcement until the final agreement was “signed and filed in court.”
Most of the 5 million recalled devices are CPAP machines, which keep airways open by delivering constant air pressure through a mask.
675 personal injury lawsuits have been filed against Philips over the recalled devices, and customers are reporting delays in getting refunds or new or refurbished machines.
Sleep apnea occurs when breathing repeatedly stops and restarts during sleep.
Approximately 39 million American adults have obstructive sleep apnea. National Council on Aging I will report.
with post wire
