Dutch medical device maker Philips said on Monday it has expanded an earlier recall of some respiratory machines to a total of 1,700 devices globally due to possible contamination of a plastic component with a non-compatible material.
The company’s subsidiary, Philips Respironics, has not received any reports of patient harm due to the issue but announced the recall to prevent future occurrences, a Philips spokesperson said.
The 1,700 devices also include 386 in the United States, but none in the company’s home country, the Netherlands-based Philips said.
The U.S. Food and Drug Administration first announced the recall on Monday, saying that if the plastic is in the device motor of the bi-level positive airway pressure (BiPAP) machines, it may release certain chemicals of concern called volatile organic compounds….