Amsterdam: Philips, the medical devices company that has been struggling with a major recall of ventilators, is recalling some of the machines it has previously replaced, according to an FDA statement.
Philips could not immediately be reached for comment on Monday. The FDA said the company had notified it that the sound abatement foam could come loose in some refurbished models, “lowing the inspiratory pressure.”
It was not clear how many of the replaced models could be affected.
Philips has replaced more than 4 million ventilators and sleep apnoea machines over the past 18 months due to worries that foam used in the machines could become toxic.