Philips halt sales of breathing machines after major recall

Paul Hoskin
·3 min read
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The Philips Center is seen on Jan. 27, 2015, in Amsterdam, Netherlands. Philips, the company behind a global recall of sleep apnea machines, said it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the company nearly $400 million.
The Philips Center is seen on Jan. 27, 2015, in Amsterdam, Netherlands. Philips, the company behind a global recall of sleep apnea machines, said it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the company nearly $400 million. | Peter Dejongm, Associated Press

Philips Respironics announced last Monday that it’s stopping sales of their breathing machines within the U.S. following a mid-2021 product recall.

The decision, as reported by The New York Times, was settled with the FDA over reports of continuing issues with the company’s ventilators and CPAP devices, or continuous positive airway pressure machines.

Philips, the Dutch manufacturing giant, is working under a tentative agreement that would cost the company almost $400 million — but company executives have reportedly “set aside $393 million for operational changes and upgrades needed to comply,” per The Associated Press.

Per USA Today, the company agreed to follow terms of a consent decree, meaning the company cannot make new sales in the U.S. until regulated improvements are made at its factories.

The Associated Press has said that under the new terms, Philips can continue to service previously sold machines in the U.S., but new ones have to be approved by the FDA under their conditions.

The company shared to the FDA, “the consent decree is being finalized and will be submitted to the relevant US court for approval,” as reported by the agency’s website. After the company receives a judge’s ratification, further details about the multiyear plan will be disclosed, as explained by The New York Times.

Philips is also facing similar litigation in Canada, Israel, Australia and Chile, according to The Associated Press. In addition, The New York Times has stated that Philips will continue to sell their products overseas.

The mid-2021 recall

Philips started their recall back in June 2021, when, according to The New York Times, they recalled — and paused selling — millions of sleep therapy machines to the U.S., citing potential cancer-causing chemicals being emitted from the devices.

Specifically, the Philips company website reported “a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices.”

As stated by U.S. News, Philips published findings that the faulty breathing devices were “not expected to result in appreciable harm to health in patients.” However, the company faced scrutiny with the FDA, calling the supposed claims “unpersuasive,” per The New York Times.

What the company has experienced since

Because of the recalls, replacement breathing devices, as reported by The Associated Press, were not immediately available for at-risk patients, which caused frustration and confusion among patients needing the devices.

Philips then received lawsuits from thousands of patients and families of patients, alleging that the breathing machines, as said by The New York Times, led to various ailments as extreme as developing lung cancer.

In September, as mentioned by U.S. News, the company agreed to a $479 million settlement to cover only the cost of repairing and replacing machines. Settlements relating to medical costs and alleged illnesses have yet to be concluded over court rulings.