After recalls Philips stops selling ventilators in the USA

After recalls, Philips stops selling ventilators in the USA

Dutch medical device maker Philips said Monday it will stop selling sleep apnea breathing machines in the United States following a series of recalls.

In 2022, the affair over defective respiratory masks plunged the former electronics giant, which had become a medical device company, into the red and led to the loss of thousands of jobs.

“Resolving the impact of the Respironics recall on our patients and customers is a priority and I recognize and apologize for the distress and concern this has caused,” Philips CEO Roy Jakobs said in a statement.

The company emphasized that it had reached an agreement with the American authorities, which consisted of a “roadmap” with goals that would allow 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 ventilator devices in the United States,” she said. added.

The group said it had allocated 363 million euros in the fourth quarter to complete the deal, which has not yet been completed and requires court approval.

The US Food and Drug Administration (FDA) recommended that patients using the Philips DreamStation 2 device in November 2023 carefully monitor the device “for signs of overheating.”

The problem appeared to be unrelated to a previous massive device recall in 2021 that plunged the company into the red in 2022, although some DreamStation 2 devices were sent as replacements.

In June 2021, the FDA warned the company about potential health risks posed by certain types of ventilators used for sleep apnea. 15 million devices worldwide are affected.

Users risked inhaling or swallowing pieces of toxic sound-absorbing foam that could cause irritation and headaches. The group also mentioned a “potential” risk of long-term cancer at the time.

The former electronics giant said in May it was “unlikely” its devices would harm patients, but U.S. health regulators called for additional testing in October.