The U.S. Food and Drug Administration issued a Class I recall Friday, the most serious type of recall, for certain Philips Respironics DreamStation1 CPAP machines.Related video above: Sleep apnea sufferers troubled by CPAPs could try new treatmentA 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. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed."The problem could lead to serious health problems such as heart failure, respiratory failure or death, the FDA says.Phillips has received 43 complaints about the issue, but there have been no reported injuries or deaths.These machines help with certain breathing conditions that don't allow people to breathe in a regular rhythm. 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.The recall involves 1,088 machines distributed from Dec. 1, 2021, to Oct. 31, 2022.Philips has sent letters to affected customers to encourage them to continue to use the devices until a replacement is sent or their health care provider makes pressure changes on their current device.The fastest way to manage the problem, the FDA says, is to contact the provider to ask about a manual reset of pressure, either remotely or in person.For further details, call 1-877-387-3311, email patientsupport@philips.com or visit Philips' website.

The U.S. Food and Drug Administration issued a Class I recall Friday, the most serious type of recall, for certain Philips Respironics DreamStation1 CPAP machines.

Related video above: Sleep apnea sufferers troubled by CPAPs could try new treatment

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. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed."

The problem could lead to serious health problems such as heart failure, respiratory failure or death, the FDA says.

Phillips has received 43 complaints about the issue, but there have been no reported injuries or deaths.

These machines help with certain breathing conditions that don't allow people to breathe in a regular rhythm. 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.

FDA

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.

The recall involves 1,088 machines distributed from Dec. 1, 2021, to Oct. 31, 2022.

Philips has sent letters to affected customers to encourage them to continue to use the devices until a replacement is sent or their health care provider makes pressure changes on their current device.

The fastest way to manage the problem, the FDA says, is to contact the provider to ask about a manual reset of pressure, either remotely or in person.

For further details, call 1-877-387-3311, email patientsupport@philips.com or visit Philips' website.

An Oklahoma woman is still waiting for a life-saving machine after the U.S. Food and Drug Administration recalled millions of the device.One of the largest manufacturers of machines that help people with sleep apnea has been recalled. An FDA investigation found that some of the machines were potentially releasing cancer-causing particles or chemicals.The recall started back in June, but those who are dependent on these lifesaving devices are still waiting for their replacement.Dr. Juanita Johnson has been waiting for over a month for a CPAP machine. She has relied on her machine to sleep safely after she suffered a stroke back in 2018."It's extremely important. I don't think I would have survived if it were not for the CPAP," Johnson said.However, for the past month, she has been without the machine. She has had to sleep upright since her CPAP machine went up in smoke."I was asleep and I woke up cause I could smell something. My CPAP machine was smoking," Johnson said.She has been trying to replace it ever since, but she can’t find one anywhere."When I called the place that I got it, the insurance paid for it, they told me there was a shortage and they didn't know when they'd be able to get another one," Johnson said.Some medical supply companies have said the massive recall has left their shelves empty."Yeah, we're still waiting. I mean, the last CPAP we had here was probably, oh gosh, a couple months ago?" said Connor Reyburn, a sales associate at Lindsey Medical Supply in Edmond, Oklahoma.Philips Respironics had to recall 34 million CPAP, BIPAP and other ventilators after the FDA found the foam used to reduce sound and vibration in the devices could degrade and enter the air pathway, which could potentially leave people to breathe in life-threatening foam particles or chemicals.Philips is in the repair process, but now millions with sleep apnea are left waiting and sleeping in fear."I think that may be why I don't sleep well. I get concerned about- they find people dead, ya know? I know it's serious," Johnson said.Philips expects the repair process to take a year, hopefully wrapping up this September.Johnson received some good news, though, and her new CPAP machine is expected to be delivered Friday.You can see if your device is part of the recall here or here. Watch the video above for the full story.