April 10, 2023 – 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.

“Incorrect therapy or therapy failure may lead [to] several health conditions such as respiratory failure, heart failure, serious injury, and death,” the FDA warned.

The recall applies to specific models of Philips Respironics DreamStation1 machines. Users will need to check the serial number on their device to see if a machine is affected. 

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.

The FDA notice says 1,088 machines are impacted by the recall, and so far 43 complaints have been filed with the agency. No deaths or injuries have been reported.

Sleep apnea is a sleep disorder that causes a person to repeatedly stop and restart breathing. Devices called CPAP and BiPAP machines help maintain a regular breathing rhythm.

The FDA said affected customers were mailed letters about the latest recall on Feb. 10. Philips is also trying to contact affected customers by phone to arrange reprogramming or replacement of the devices, which are used in people’s homes, hospitals, and health care settings.

People may call Philips at 877-387-3311 or email the company at [email protected] for more information.

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