The US Food and Drug Administration issued a Class I recall, the most serious type of recall, for certain Philips Respironics DreamStation1 CPAP machines.
A Class I recall means the FDA has determined a reasonable probability that a product could “cause serious adverse health consequences or death.” “Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming,” the recall notice says. “This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all.
The machines provide continuous positive airway pressure, known as CPAP, to keep the airways open with a steady stream of air through a mask or bilevel positive airway pressure, also known as BiPAP support, pumping air into the lungs using different pressures. People who have sleep apnea or obstructive sleep apnea, potentially serious disorders in which they may stop breathing at night, can use these machines to keep their airways open during sleep.
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