Philips ( PHG.US ) said on Tuesday that tests of its recalled ventilators showed that degraded foam in 95 percent of the devices was “unlikely to cause appreciable harm to patients’ health.” Philips first recalled potentially defective breathing devices in June 2021, which the U.S. Food and Drug Administration (FDA) also identified as a Class I recall, the most serious type of recall.
Shares in Philips rose 6 percent in Amsterdam after the news, to their highest level since last August.
Philips has set aside about 1 billion euros ($1.1 billion) to recall about 5.5 million devices worldwide and set aside 575 million euros for related legal costs.
In the US, Philips faces multiple class action lawsuits and individual personal injury claims. Consumers accused the company of violating the U.S. federal Food, Drug and Cosmetic Act, which requires medical devices to be safe and effective. They claim the ventilators are flawed in their design and use foam that degrades if exposed to moisture.
The test results could help Philips defend itself against health claims. The FDA is still considering the data provided by the company, and the agency may come to different conclusions.
