Following initial recall, reworked sleep apnea machines are recalled

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Phillips has recalled more than 1,000 reworked Respironics DreamStation CPAP, BiPAP machines.

The machines, initially recalled in June 2021, may still not be working correctly.

In a statement posted on the Food and Drug Administration’s website, Phillips says the machines were assigned duplicate or incorrect serial numbers during initial programming.

“This duplication can cause therapy to be delivered using the wrong prescription or factory default settings,” the notice says. “Additionally, it may fail to deliver any therapy at all.”

Phillips says there is no warning that the machine is not working as intended.

MORE: Recall of Philips CPAP device causing worldwide shortage

People with sleep apnea use machines to help them breathe properly during sleep.

The products are part of a Class I recall, which is the most serious type of recall.

“Use of these devices may cause serious injuries or death,” the FDA states.

Phillips has reportedly received 43 complaints about the reworked machines. The company says there are currently no reports of injuries or deaths linked to the machines.

Phillips has sent customers a notice with information about how to identify whether their machine is part of the latest recall.

They can continue to use the machine until they receive a replacement or pressure changes are made by their provider.

Customers can contact Phillips with any other questions by emailing the company at respironics.clinical@philips.com.

By Scripps News

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