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Philips investigates FDA report on fans



(Reuters) – Dutch medical device maker Philips said on Wednesday that US regulators may have overestimated the number of safety concerns raised by customers related to their recall of fans using a potentially dangerous foam.

The US Food and The Drug Administration said this month that Philips' health risk assessment was inadequate, as it had found tens of thousands more complaints in the company's customer database than the nearly 1,250 reported by Philips.

"The complaints referred by the FDA are the result of a very broad search. Therefore, the complaints did not necessarily specifically concern the problem that led to the recall, "Philips CEO Frans van Houten told reporters.

In September, Philips estimated that it would replace up to 4 million fans and respirators due to some polyurethane foam. which could deteriorate and become toxic.

Philips shares have lost about a third of their value since announcing the recall in April as investors fear the issue will lead to large claims.

They fell to their lowest level since March last year. years after the FDA said on November 1

2 that they had found new problems at the Dutch company's manufacturing facility.

Mr. Van Houten said that Philips looked closely at all the questions asked by the FDA and that he would carefully examine the number of complaints that the regulator found.

"Not all records in the database are actually a security issue or a defect," he said.

"Together with the FDA, we need to go through the details and show what is related to the particles and what were the innocent issues."

Philips has so far set aside € 500 million ($ 560 million) in provisions for recall costs. In October, it lowered its financial forecasts for the year, citing the fallout from the recall and related lawsuits.

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