Philips (PHG.US) said it has reached a final agreement with the US Department of Justice and the Food and Drug Administration (FDA) on a consent order relating to ventilators.
The Zhitong Finance App learned that Philips (PHG.US) said it has reached a final agreement with the US Department of Justice and the Food and Drug Administration (FDA) on a consent order relating to ventilators.
Under the agreement, Philips Respironics (Respironics) ventilators will continue to prioritize the restoration of sleep and respiratory care devices that were voluntarily recalled in 2021.
In June 2021, Philips announced the recall of millions of sleep apnea and ventilators, saying that patients may inhale a foam particle and gas that can degrade and release harmful and potentially carcinogenic foam particles and gases when using these devices; in 2021 alone, Philips recalled 5.2 million respiratory devices worldwide, far higher than the initial estimate of 3 million to 4 million.
Philips CEO Roy Jakobs said in a statement: “With the agreement, we now have a clear path forward to gradually resume business and serve patients around the world.”
Philips said on Wednesday that its 2023-25 median comparable sales growth rate and adjusted EBITDA margin of less than 10% remain unchanged, and its free cash flow forecast of €1.4 billion to €1.6 billion has now taken the agreement into account.