The Food and Drug Administration (FDA) on Friday classified the recall of Philips’s respiratory machines as its most serious type, as their use could cause serious injuries or death.
The Dutch medical devices maker’s unit Philips Respironics recalled 1,088 devices in the United States on Feb. 10.
These devices help people with respiratory conditions to keep breathing at a regular rhythm.
Philips was recalling the machines as some devices were assigned incorrect or duplicate serial numbers during initial programming, the U.S. health agency said.
The duplication could cause therapy to be delivered using the wrong prescription or factory default settings, it added….