Philips and U.S. regulators are continuing discussions regarding internal investigations at the company following a recall of its ventilators earlier this year, where parts being used contained a potentially hazardous foam.
On Nov. 12, the U.S. Food and Drug Administration (FDA) said that it had obtained new information during inspections of the company’s Murrysville, PA facility. read more
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.
Read the full article on Reuters.
