Second, the PE-PUR foam may emit certain chemicals that could be inhaled.
First, the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user. The recall is due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators. The recall encompasses all serial numbers of these devices manufactured between 2009 and April 26, 2021. Philips has also issued a recall for the following ventilators: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models.
Specifically, the following CPAP and BiPAP devices were recalled: E30, DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+, SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto. On June 14, 2021, Philips Respironics issued a voluntary medical device recall for millions of its CPAP devices, BiPAP devices, and mechanical ventilators.
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