In order to address potential health risks associated with the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP, and mechanical ventilator devices, Philips Respironics, a Philips subsidiary, initiated a voluntary recall notification/field safety notice on June 14, 2021. 5.5 million devices are expected to be repaired or replaced globally by Philips Respironics, and CPAP and BiPAP sleep apnea devices account for about 95% of the registered impacted devices. The PE-PUR sound abatement foam is swapped out for silicone foam as part of the maintenance and replacement programme. Globally, the process of repairing and replacing CPAP and BiPAP sleep apnea machines is well under way.
Following the preparations and relevant clearances, the repair of Trilogy 100/200 ventilators (approximately 3% of the registered affected devices globally) has started in recent months. Philips Respironics has now detected two problems with corrected Trilogy 100/200 ventilators following a limited number of complaints from the US and Japan. These problems only affect the Trilogy 100/200 ventilators that have already been repaired.