The US Food and Drug Administration (FDA) is still not satisfied with how technology company Philips has handled a major product recall and instructed the company to conduct additional risk testing.
The Dutch healthcare giant has recalled millions of sleep apnoea and respiratory devices in an ongoing process since 2021, reports Reuters.
In its statement, the FDA said it did not believe” that the testing and analysis Philips has shared … are adequate to fully evaluate the risks posed to users from the recalled devices”.
In response, Philips said five independent laboratories had tested the recalled devices but it has agreed with the FDA’s call for more tests and was in discussions with the agency on details.
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 has tallied 100 000 complaint reports over the machines, and 385 deaths.
Philips lost more than two-thirds of its market valuation in 2021-2022 due to the recall, but has staged a modest recovery in 2023.
In its recall update, the FDA has added a new resource section to its website, incorporating feedback from patients and a comprehensive timeline.
Last month, Philips settled one major category of legal claims over the recall, for which it had earlier taken a $606m provision.
However, the company still faces personal injury claims, as well as an investigation by the US Department of Justice. It is in talks with the FDA over a “consent decree” or settlement.
Reuters article – US FDA still not satisfied with Philips recall (Open access)
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