AMSTERDAM, (Reuters) – Philips, a medical equipment manufacturer, is now in dicussions after a fresh inspection at one of its facilities.

Philips announced in September that it would repair or replace 15,000,000 of the affected devices due to a silicone-based foam component which could degrade and become toxic. This can potentially cause cancer.

In a form 483, the FDA announced that 14 incidents of potential foam degradation were discovered by Philips between January 2016 and February 2021.

Philips was requested by FDA to do additional testing on the foam that was used in the recalled ventilators. It stated that it hasn’t sufficiently proven other products containing this foam shouldn’t be recalled. Also, it said that Philips’ methods for designing change might not be sufficient.

“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 these talks are concluded, we cannot publicly disclose any further information.”

The company stated that it would complete its own foam testing in the fourth quarter.

A replacement foam is being developed by the company, which has also been subject to further testing.

Philips has thus far set aside 500 million euro ($572.50 millions) in reserves for recall costs. It reduced its financial projections for this year in October, citing the fallout of the recall and the related lawsuits.

($1 = 0.8734 euros)