US FDA identifies recall of Philips' respiratory devices as most serious
Send a link to a friend
[August 15, 2023]
(Reuters) - The U.S. Food and Drug Administration (FDA) on Monday
classified the recall of Philips' respiratory machines as its most
serious type, as their use could cause serious injuries or death.
The Dutch medical devices maker started the process on March 29 and has
recalled 73,000 devices in the United Sates.
The ventilators being recalled include Trilogy Evo, Evo O2 and EV300,
among others. These devices help people with respiratory conditions to
keep breathing at a regular rhythm.
Philips was recalling the ventilators after detecting contaminants such
as dust and dirt from the environment in the air path of some devices.
[to top of second column]
|
Philips Healthcare headquarters is seen
in Best, Netherlands August 30, 2018. Picture taken August 30, 2018.
REUTERS/Piroschka van de Wouw
The company has received 542 reports
about this issue, according to the FDA. The health agency said there
are currently two reported injuries and one death attributable to
the issue.
The devices were distributed between March 26, 2019 and March 22,
2023.
(Reporting by Pratik Jain in Bengaluru; Editing by Shounak Dasgupta)
[© 2023 Thomson Reuters. All rights
reserved.]This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content. |