Philips shares tumble after FDA inspection of U.S. facility
Koninklijke Philips PHIA, -11.40% PHG, +0.17% was on track for its worst single session in 19 years, falling 9.6%, after the Food and Drug Administration's inspection of a U.S. facility, following a recall of breathing assistance machines. The FDA said it obtained information during an inspection about the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals.
"The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.," the agency said.
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