Philips in talks with FDA about ventilator issues

posted by mike kraft on Sun, 2021-11-14 21:28

Philips in talks with FDA after new ventilator findings - statement Philips , the medical equipment maker that is recalling ventilators due to use of parts containing a potentially hazardous foam, said on Sunday it is in dicussions with U.S. regulators after a new inspection of one of the company's facilities. Reuters Reuters

AMSTERDAM, Nov 14 (Reuters) - Philips (PHG.AS), the medical equipment maker that is recalling ventilators due to use of parts containing a potentially hazardous foam, said on Sunday it is in dicussions with U.S. regulators after a new inspection of one of the company's facilities.

Philips in September estimated it will replace up to 4 million vetilators and respiratory devices because of a polyurethane foam part that might degrade and become toxic. read more

The company has produced 15 million devices using the foam since 2009 but some are not in use.

On Nov. 12, the U.S. Food and Drug Administration (FDA) said that it had obtained new information during inspections of the company's Murraysville, PA facility. read more ...

Country / Region Tags:

General Topic Tags: