AMSTERDAM (Reuters) – Philips, the medical equipment maker that is recalling ventilators due to use of parts containing a potentially hazardous foam, said on Sunday it is in dicussions with the U.S. Food and Drug Administration (FDA) after a new inspection of one of the company’s facilities.
Philips in September said it will repair and replace 15 million affected devices because of a silicone-based foam part that might degrade and become toxic, potentially causing cancer.
On Nov. 11 the FDA said, in a so-called form 483, that an inspection found that between April 2016 and January 2021 Philips was aware of 14 instances of issues related to potential foam degradation with its devices.
The FDA asked Philips to conduct more tests on the foam used in the recalled ventilators and said the company has not sufficiently demonstrated that other devices containing the foam should not also be recalled. It also said Philips’ procedures for design change may not be adequate.
“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing,” Philips CEO Frans van Houten said in a statement.
“Until we have concluded these discussions, we are not able to publicly provide further details.”
It said it expected to complete its own testing of the foam in the fourth quarter.
The company is also working on a replacement foam which is also undergoing further testing.
Philips has so far put aside 500 million euros ($572.50 million in provisions for recall costs. In October it lowered financial forecasts for the year, citing fallout from the recall and related lawsuits.
($1 = 0.8734 euros)
(Reporting by Toby Sterling;Editing by Elaine Hardcastle)
