April 10, 2023 – Some Philips Respironics sleep apnea devices are being recalled for the second time, the FDA announced.
This latest recall has been upgraded by the FDA to a Class I recall, which is essentially the most serious form of recall the agency issues. The faulty devices “may not be able to deliver therapy at all,” the recall notice states.
“Incorrect therapy or treatment failure can lead to [to] “This can lead to a variety of health problems, including respiratory arrest, heart failure, serious injury, and death,” the FDA warned.
The recall applies to specific models of Philips Respironics DreamStation1 devices. Users must check the serial number on their device to find out if a tool is affected.
In a previous recall nearly two years ago, Philips attempted to “reengineer” the ventilators, but “some devices were assigned incorrect or duplicate serial numbers when they were first programmed. This duplication can result in therapy being delivered using the wrong prescription or factory settings” or within the devices not delivering therapy in any respect. Faulty devices provide no indication that anything is improper.
According to the FDA announcement, 1,088 machines are affected by the recall and 43 complaints have been filed with the agency up to now. No deaths or injuries have been reported.
Sleep apnea is a sleep problem wherein respiratory repeatedly stops and resumes. Devices called CPAP and BiPAP machines help maintain a daily respiratory rhythm.
The FDA said letters concerning the latest recall were sent to affected customers on February 10. Philips can also be attempting to achieve affected customers by phone to rearrange reprogramming or alternative of the devices, that are utilized in homes, hospitals and healthcare facilities.
You can call Philips at 877-387-3311 or email the corporate at [email protected] for more informations.