Philips on Monday flagged more problems with some ventilators that it has previously replaced, as per an FDA statement. According to a report by the news agency Reuters, the company has been struggling with a major recall of ventilators.
A Philips spokesperson said, as quoted by Reuters, that only Trilogy 100/200 ventilator models were potentially affected.
The FDA said the company had notified it that the sound abatement foam could come loose in some refurbished models, “lowering the inspiratory pressure”.
In addition, trace amounts of particulate matter were found in air pathways of some reworked ventilators, as per Reuters.
According to reports, Philips has replaced more than 4 million ventilators and sleep apnoea machines over the past 18 months due to worries that the foam used in the machines could become toxic.
The spokesperson said Trilogy 100/200 ventilators represent around 3 percent of the recall, and no sleep apnoea machines were affected.
ALSO READ | Medical device industry needs to act on environmental sustainability: GlobalData
Philips shares declined 1.3 percent to 13.55 euros in Amsterdam.
(With inputs from Reuters)