The U.S. Food and Drug Administration (FDA) on Friday classified the recall of Philips' respiratory machines as its most serious type, as their use could cause serious injuries or death.
April 7 - The U.S. Food and Drug Administration on Friday classified the recall of Philips'The Dutch medical devices maker's unit Philips Respironics recalled 1,088 devices in the U.S. on Feb. 10.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 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.
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