Philips recalls some previously replaced ventilators -FDA statement
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[November 21, 2022]
AMSTERDAM (Reuters) - Philips, which has been struggling with a
major recall of ventilators, is recalling some machines it has
previously replaced, according to an FDA statement.
A Philips spokesperson said on Monday that only Trilogy 100/200
venilator 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.
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.
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Logo of Dutch medical equipment maker
Philips is seen at its company headquarters in Amsterdam,
Netherlands, January 29, 2019. REUTERS/Eva Plevier
The spokesperson said Trilogy
100/200 ventilators represent around 3% of the recall, and no sleep
apnoea machines were affected.
(Reporting by Toby Sterling; editing by Louise Heavens and Jason
Neely)
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