Philips falls, FDA not satisfied with recall of millions of respiratory devices

(Reuters) – Philips fell on the stock market on Friday after the US Food and Drug Administration (FDA) said it was still not satisfied with the way the Dutch healthcare company handled a major recall of ventilators blamed for their potentially carcinogenic nature.

The US health authority has requested that Philips carry out additional risk assessments. On the Amsterdam Stock Exchange, the stock plunged 10% to 16.70 euros at 08:05 GMT on Friday, heading for its biggest daily drop in a year. The value showed the biggest decline in the Stoxx 600 index, up 0.44% at the same time.

The FDA notice is a new blow for Philips, which in June 2021 recalled millions of respiratory aid devices and ventilators used for sleep apnea due to a risk of degradation and toxicity. ‘a foam component which could become carcinogenic.

“We do not believe that the testing and analysis that Philips has conducted to date is sufficient to fully assess the risks posed to users by the recalled devices,” the FDA said in an update released Friday.

Philips agreed with the FDA’s request for additional testing and said it was discussing details with the agency. “Philips’ first priority is the health and well-being of patients, whether that’s supplying replacement devices or testing to ensure that sleep and breathing devices that work “Recalled items are safe to use,” the company said. “This is negative news,” Bernstein analysts said in a note. “The requirement for additional testing, continued dissatisfaction with Philips’ handling of the recall, and the removal of the device from the shortage list make a ban on the sale of Respironics in the United States all the more likely,” they added. -they.

In France, a complaint was filed by 217 people before the Paris public health center against Philips in this respirator affair.

(Reporting Toby Sterling and Piotr Lipinski, French version Corentin Chappron, edited by Blandine Hénault)