Some sleep apnea machines made by Philips Respironics are being recalled for a second time, the FDA announced.
This latest recall has been upgraded by the FDA to a Class I recall, which is the most serious type of recall the agency issues. The faulty machines “may fail to deliver any therapy at all,” the recall states.
During a previous recall nearly 2 years ago, Philips attempted to “rework” the breathing machines. But “some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings,” or result in no therapy being delivered by the machines. Faulty machines won’t give any indication that something is wrong.
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