It was announced yesterday by the Dutch medical device company, Philips, that it will stop selling sleep apnea devices in the United States following a series of product recalls from the market.
In 2022, flaws in respiratory devices sold in the market caused significant losses for the former electronic giant, which has since specialized in selling medical equipment, leading to the cancellation of thousands of jobs.
CEO of the company, Roy Jakobs, stated in a press release, “Solving the consequences of withdrawing our Respironics devices for our patients and customers is a priority, and I am aware of the distress and concern it has caused, and I apologize for it.”
Philips confirmed that it has reached an agreement with the US authorities that includes a “roadmap” for objectives allowing the company to comply with regulatory requirements.
The group stated that it has allocated 363 million euros to settle the agreement in the fourth quarter, which has not yet been concluded and requires court approval.
The US Food and Drug Administration (FDA) advised in November 2023 that patients using the “Philips DreamStation 2” monitor the device carefully for any signs of excessive wear.
This issue appeared separate from the massive device recall in 2021 that resulted in losses for the group in 2022, despite sending some “DreamStation 2” devices as replacements.
In June 2021, the US Food and Drug Administration alerted the company to potential health risks posed by certain types of mechanical ventilators used for sleep apnea, affecting 15 million pieces of equipment worldwide.
Users faced the risk of inhaling or swallowing toxic foam particles that could cause irritation and headaches. The group also indicated the “potential” risk of long-term cancer exposure.
In May 2023, the former electronic giant stated that it was “unlikely” that its devices would harm patients, but US health authorities requested additional tests in October of the same year.
