Philips CPap, APap, BIPap and Mechanical Ventilator Machine Recalls:
On June 30, 2021, the U.S. Food and Drug Administration (FDA) issued a Class I recall on Philips Respironics Ventilators, BiPAP, and CPAP Machines due to potential health risks. A class I recall is the most serious recall and is a situation where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The polyester-based polyurethane (PE-PUR) sound abatement foam may break down. The material is designed to lessen the machine noise but it is part of the user’s airway which may cause the toxic particles to enter the user’s air pathway. When this occurs, the black debris from the foam or certain chemicals released may be inhaled or swallowed by the person using the device. There have been reports of headaches, upper airway irritation, cough, chest pressure, and sinus infections as well as more serious injuries, including organ damage, and cancers including nasal cancer, throat and soft palate cancer, thyroid cancer, lung cancer and other rare cancers.
Different models of a variety of Philips’ sleep and respiratory care devices have been affected by the product recall including Bi-level Positive Airway Pressure Devices also known as Bi-Level PAP or BiPAP, Continuous Positive Airway Pressure Machines or CPAP Machines, and Mechanical Ventilators. Of the roughly 3 to 4 million recalled Philips devices, about 80% of the affected products are CPAP machines.
If you have experienced side effects that are related to your use of Philips Respironics Ventilators, it is important to contact Oliver Law Office for a free consultation to determine if you may be entitled to financial compensation.