Recalled Philips BiPAP and CPAP machines
According to an update from the U.S. Food & Drug Administration (FDA), Philips Respironics (Philips) in June 2021 recalled certain sleep and respiratory care devices including ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines because of potential health risks.
The recall was issued to address the breaking down of the polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration. If the foam breaks down, black pieces of foam, or certain chemicals of concern, called volatile organic compounds (VOCs) that are not visible, could be breathed in or swallowed by the person using the device. Breathing in certain chemicals or swallowing small pieces of foam could result in potential health risks. The PE-PUR foam breakdown issue may result from exposure to hot and humid conditions and may be worsened by using ozone cleaners or other cleaning methods not recommended by the manufacturer.
Philips issued a statement stating they “will no longer accept registrations for affected CPAP and BiPAP devices in the United States after Dec. 31, 2024.” Anyone who would like to receive a replacement device or financial reimbursement must register their device by this date.
Dr. David Kuhlmann, medical director at Bothwell Sleep Center, urges people to address their recalled devices as soon as possible.
“The Philips recall is affecting many people,” he said. “If someone has one of these devices, they should first and foremost no longer use it, and second, they should register the affected device to be eligible for a replacement or financial payment. People who haven’t registered their device yet may benefit from a physician visit and new sleep study to reassess current health issues.”
For more information about the recalled devices or to schedule an appointment with Dr. Kuhlmann, call Bothwell Sleep Center at 660.827.9573 or Centralized Scheduling at 660.829.8888.