AMSTERDAM (Reuters) – Philips, which is grappling with a major ventilator recall, is recalling some machines it previously replaced, according to a statement from the FDA.
A Philips spokesperson said Monday that only Trilogy 100/200 fan models may have been affected.
The FDA said the company had made it known that the sound-deadening foam in some refurbished models could come off, “lowering inspiratory pressure.”
In addition, traces of particulate matter were found in the air ducts of some reworked fans.
Philips has replaced more than 4 million ventilators and sleep apnea devices in the past 18 months over fears that foam used in the machines could become toxic.
The spokesperson said Trilogy 100/200 ventilators accounted for about 3% of the recall and no sleep apnea machines were affected.
(Reporting by Toby Sterling; editing by Louise Heavens and Jason Neely)