The United States Food and Drug Administration announced on Tuesday that a federal court in the United States granted a ruling that would prohibit the production and sale of sleep apnea devices manufactured by Philips (PHG.AS), opens new tab new sleep apnea machines at various facilities around the country.
Philips Respironics, a subsidiary of the corporation, has been subjected to what is known as a consent decree by the United States District Court for the Western District of Pennsylvania.
This order is intended to restrict sales and production until certain requirements are satisfied.
As part of its efforts to comply with a settlement with the Food and Drug Administration (FDA), the Dutch health technology business said in January that it will not sell any new devices targeted toward the treatment of sleep apnea in the United States in the days and years to come.
The deal came about as a result of the recall of millions of breathing devices and ventilators that were used to treat sleep apnea in 2021. The reason for the recall was due to worries that the foam that was used to minimize noise from the devices could degrade and become toxic, which potentially carried the risk of cancer.
In addition, the decree mandates the execution of a recall remediation plan, which must be agreed upon by both the FDA and Philips. This strategy is intended to assist in ensuring that patients who have been affected by the recall receive relief.
Some of the remediation alternatives that are outlined in the proposal include providing patients with a new or updated device, as well as the possibility of receiving a partial refund for some devices.
Philips has informed Reuters that almost all of the business's actionable registered sleep therapy devices have been remedied across the globe. The company also stated that it will employ experts to assess various areas of the remediation process.
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