The US Food and Drug Administration issued a Class I recall Friday, 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. 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 December 1, 2021, to October 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 firstname.lastname@example.org or visit Philips’ website.