To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification. For patients using affected bilevel and CPAP devices: Discontinue use of your device and work with your physician or durable medical equipment provider to determine the most appropriate options for continued treatment.Patient safety is at the heart of everything we do at Philips.” Recall Notification Advice for Patientsīased on the latest analysis of potential health risks and out of an abundance of caution, the recall notification advises patients and customers to take the following actions:
![philips recalls sleep apnea machines philips recalls sleep apnea machines](https://post.medicalnewstoday.com/wp-content/uploads/2020/04/consulting_with_doctor-732x549-thumbnail-732x549.jpg)
“In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. “We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” says Frans van Houten, CEO of Royal Philips, in a release. Therefore, Philips has decided to voluntarily issue a recall notification to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam.
![philips recalls sleep apnea machines philips recalls sleep apnea machines](https://dailyhornet.com/wp-content/uploads/2021/07/philips-cpap-machine-lawsuit.jpg)
To date, Philips has produced millions of bilevels, CPAP, and mechanical ventilator devices using the polyester-based polyurethane sound abatement foam. The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family. Philips has issued a recall in the United States, and a field safety notice for the rest of the world, for specific Philips bilevel positive airway pressure (bilevel PAP), CPAP, and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.