Dutch medical device maker Philips announced Monday that it will stop sales of sleep apnea breathing devices in the United States after a series of recalls.
In 2022, the defective respirator affair plunged the former electronics giant turned medical equipment company into the red, and led to the loss of thousands of jobs.
“Resolving the consequences of the Respironics recall for our patients and customers is a priority and I am aware of and apologize for the distress and concern caused,” Philips CEO Roy Jakobs said in a statement.
The company stressed that it has reached an agreement with the American authorities which consists of a “road map” of objectives allowing Philips to comply with regulatory requirements.
“Until the relevant requirements of the consent decree are met, Philips Respironics will not sell new … sleep therapy or other respiratory care devices in the United States,” she said. added.
The group said it had set aside 363 million euros in the fourth quarter to settle the deal, which has yet to be finalized and requires court approval.
The US Medicines Agency (FDA) advised patients using the Philips DreamStation 2 machine in November 2023 to carefully monitor the device “for any signs of overheating”.
The problem appeared separate from a previous massive device recall in 2021 that plunged the group into the red in 2022, although some DreamStation 2 machines were sent out as replacements.
In June 2021, the FDA alerted the company to potential health risks posed by certain types of ventilators used in sleep apnea, with 15 million pieces of equipment affected worldwide.
Users risked inhaling or swallowing pieces of toxic sound-absorbing foam that could cause irritation and headaches. The group also mentioned at the time a “potential” risk of long-term cancer.
The former electronics giant said in May that it was “unlikely” that its devices would harm patients, but US health authorities in October requested additional testing.
