U.S.
FDA labels Philips expanded ventilator recall as most serious
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[January 27, 2022]
(Reuters) -The U.S. Food and Drug
Administration (FDA) on Wednesday classified an expanded recall of
certain ventilators by Philips late last year as Class 1, or the most
serious type, saying they could lead to injuries or death.
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The Dutch medical equipment company initiated the recall of 215
Trilogy Evo ventilators and 51 repair kits in the United States in
December due to potential health risks from a type of foam used in
the devices.
So far, there have been no reported injuries or deaths from the
products, which were distributed in the United States and Korea, the
FDA said.
"We have already reached the majority of affected customers and we
will correct this issue via a repair (replacement of the foam) on
site in the coming months" a company spokesperson said in an emailed
statement to Reuters.
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This is the latest recall by Philips to be labeled Class 1 after it
pulled back up to 4 million breathing-aid machines last year amid
concerns that a polyurethane foam used in the devices could degrade
and become toxic.
Earlier this month, the company raised that estimate by 1 million.
A Philips supplier had incorrectly used a type of polyurethane foam,
which is intended to reduce sound and vibration, in one of the parts
of the Trilogy Evo ventilators - an issue that was identified during
lab testing, the regulator said on Wednesday.
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![](http://archives.lincolndailynews.com/2022/Jan/27/images/ads/current/xamis_lda_LUAL_2016.png) The supplier used polyester-based polyurethane
foam instead of a polyether-based one which is
specified for these products and meets all
applicable standards, Philips said in the email.
The polyester-based foam could break down and
potentially enter the device's air pathway,
leading to the user inhaling chemicals or other
harmful materials, the FDA said.
($1 = 0.8880 euros)
(Reporting by Amruta Khandekar; Editing by
Devika Syamnath and Sriraj Kalluvila)
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