FDA questions Philips assessment of patient risk
Philips consents to additional testing
Shares fall more than 9 in morning trading

AMSTERDAM, Oct 6 Reuters The U.S. Food and Drug Administration FDA said it is still not satisfied with how Dutch healthcare technology company Philips has handled a major product recall and the company should conduct additional risk testing.

Its shares fell 9.6 to 16.81 euros at 0726 GMT on Friday.

It was the latest blow to Philips over the recall of millions of sleep apnea and respiratory devices, which has been ongoing since 2021.

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 FDA said in an update published overnight.

In response, Philips said it had 5 independent laboratories test the recalled devices but it has agreed with the FDA39;s call for more and was in discussions with the agency on details.

Philips first priority is the health and wellbeing of patients, both in terms of providing replacement devices and testing to seek more clarity on the safety of the sleep and respiratory care devices under the recall, it said.

CEO Roy Jakobs has made the recall his top priority since being appointed in October 2022 after his predecessor stepped down.

The recalled devices used a type of foam that could degrade when exposed to cleaning chemicals, causing injuries to airways or leading to cancer, the FDA has said. It…