FDA Approves Philips Respironics’ Plan for Reworking Recalled Ventilators, CPAPs
September 14, 2021
WASHINGTON, D.C. — The Food and Drug Administration has approved Philips Respironics’ plan to rework and replace certain ventilators, bi-level positive airway pressure, and continuous positive airway pressure machines, which had been recalled due to potential health risks.
According to the Sept. 13 MedWatch update, the plan targets recalled DreamStation CPAP and BiPAP machines, specifically DreamStation CPAP; Pro, Auto, Dream Station BiPAP; Pro, Auto and DreamStation ST, ASV, AVAPS.
The polyester-based polyurethane (PE-PUR) sound abatement foam used to reduce sound and vibration in those devices may break down and potentially enter the device’s air pathway, according to the …