Philips Shares Slump After Update On Recall Of Respiratory, Sleep Devices - Koninklijke Philips (NYSE:PHG)

Koninklijke Philips NV PHG said it is in discussions with the FDA after a new inspection of one of its facilities.
Philips in September estimated it would replace up to 4 million ventilators and respiratory devices because of a polyurethane foam part that might degrade and become toxic.
On November 12, the FDA had obtained new information during inspections of the company's Murraysville, PA facility.
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 might 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 testing of the foam in the fourth quarter.
The company has been using a replacement silicone-based foam which must now also undergo further safety testing.
Price Action: PHG shares are down 10.7% at $42.52 during the premarket session on the last check Monday.