Koninklijke Philips PHIA, -1.07% PHG, -0.47% 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. Philips said it’s conducted testing to support the new silicone replacement form, which it said demonstrated acceptable results, and will continue to coordinate with the FDA.
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