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The US Food and Drug Administration has said steps taken by Philips to test its sleep apnoea breathing machines that have been subject to a wide-ranging recall are inadequate, sending shares in the company down 10 per cent.
“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” the regulator said in a statement overnight. “The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.”
The company began its recall of certain Philips breathing machines because of potential health risks in 2021 — affecting a total of 15mn devices globally. The polyurethane foam used in the devices to reduce sound and vibration “can break down”, and certain chemicals “could be breathed in or swallowed by the person using the device”, according to the FDA, resulting in potential serious injury. Because some devices are no longer in use, Philips expects its programme to target up to 5.6mn machines.
Philips said it had been “working cooperatively with the FDA on the test and research program [of its range of sleep apnoea machines] and published regular test updates as agreed” with the regulator.
It said it had conducted “extensive” testing with five independent laboratories and concluded “that use of its sleep therapy devices are not expected to result in appreciable harm to health in patients”.
It added that it had agreed to implement additional testing, but stressed that the despite its concerns, the FDA had recognised that testing had been “extensive and conducted with independent parties and expressed no concerns with the validity or objectivity of the testing”.
The company said its main priority was the health and wellbeing of patients.
This article has been updated to clarify that Philips initiated the recall of sleep apnoea machines and that the programme targets 5.6mn devices.
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