AMSTERDAM—Philips clarified that 2.2 million devices it has repaired or replaced in a major recall of respiratory devices are actually in the hands of patients in the United States.
The FDA on April 7 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’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.
The company has received 43 complaints about the issue, according to the FDA. It said there were currently no reported injuries or deaths attributed to it.
The devices were distributed between Dec. 1, 2021 and Oct. 31, last year.
The company said affected units may continue to be used in accordance with device instructions, adding that it was reaching out to patients to arrange for the units’ replacement and return.
