A consumer alert has been issued for users of respiratory devices manufactured by Philips. An estimated 4 million Philips Continuous Positive Airway Pressure (CPAP) and Bi-Level Positive Airway Pressure (BiPAP or BiLevel PAP) devices, as well as mechanical ventilators manufactured before April 26, 2021.
The recalls are due to potential health risks associated with the sound abatement foam in the devices.
The Delaware Department of Insurance announced that it issued the notice after the company’s recall notification and what it views as a lack of communication to consumers and facilities.
Recalled devices include those listed as providing respiratory treatment or support for Covid-19 patients. CPAP devices are used by individuals who suffer from sleep apnea, a disorder that leads to a temporary stop to breathing during sleep and can lead to death. (Images above are from the U.S. Department of Veterans Affairs)
While the recall notice urges immediate discontinuation of device use if possible, some individuals require the use of CPAP, BiPAP, and ventilator devices and may face serious medical issues, including the possibility of death, if they do not have access to a machine.
Residents using medically necessary devices should contact their physician to discuss the best path forward for their individual needs and register in the Philips recall system online or call 1-877-907-7508 to begin a claim for replacement or financial restitution, the Insurance Department release stated.
Users should not make any changes to their equipment or treatment plan without discussing the matter with a physician. Doctors are asked to communicate with their patients, and facilities should check all machines.
At this time, the company has not provided a replacement or repair timeline after issuing notice in June that the sound abatement foam in these devices may degrade, be ingested, and create additional respiratory problems, and could be releasing carcinogenic or otherwise hazardous chemicals into the air pathway.