(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.
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)
