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FDA Upgrades Recall for Some Sleep Apnea Devices to Class I
The US Food and Drug Administration (FDA) has recalled some sleep apnea machines manufactured by Philips Respironics for the second time, with this latest recall upgraded to Class I, the most serious type of recall that the agency can issue.
Phillips recalled 20 different devices in April 2021, including A-Series bilevel positive airway pressure (BiPAP) ventilators and the DreamStation continuous positive airway pressure (CPAP) machines, due to a variety of complaints ranging from reports of cancer, respiratory problems, pneumonia, chest pain, dizziness, and infections. Further, in June 2021, Phillips recalled 5 million CPAP machines because internal foam designed to damped noise was breaking off the machine and blowing into users’ mouths.
Phillips attempted to repair and reissue the faulty devices, leading to the current recall. According to the FDA, certain “reworked” DreamStations were assigned incorrect or duplicate serial numbers during the programming, which can result in delivery of the wrong therapy or “may fail to deliver any therapy at all.”
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While no injuries or deaths have been reported, the FDA warns that incorrect therapy or therapy failure may result in respiratory failure, heart failure, serious injury, and/or death.
The FDA alert notes that 1088 machines are affected by the recall and that thus far, 43 complaints have been registered with the agency.
Phillips has been working to notify patients so that replacement devices can be shipped to them. In the meantime, affected customers and patients should check the serial numbers on their devices in reference to the Important Product Notice that Phillips has issued, the FDA says.
Concerned individuals may contact Phillips directly through phone or email for more information on their devices and the recall.
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