Sleep and Respiratory Care Devices Recall

Potential Health Risks Related to Certain Sleep and Respiratory Care Devices

In June 2021, Philips initiated a voluntary recall for some devices used for treating breathing problems during sleep, such as sleep apnea, as well as night-time ventilators for patients with chronic respiratory failure. The recall applies to Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices.

These devices are being recalled because the foam used to make the devices less noisy (a polyester-based, polyurethane foam, also known as "PE-PUR foam") may break down and cause particles or vapors (also known as volatile compounds) to be breathed in, or inhaled. While Philips has received no reports of serious illness, a very small number of people who used these devices in 2020 (about three out of every 10,000 people) described headache, sore throat, cough or sinus congestion that may be from the foam.

Beth Israel Deaconess Medical Center (BIDMC) is acting quickly to replace affected devices throughout our hospital. Patients who use one of the impacted devices at home are instructed to register for repair or replacement with Philips.