Continuous non-life-supporting ventilator devices including the DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+.Philips Respironics on June 14 sent customers an “Urgent: Medical Device Recall” letter telling them to discontinue use of their machines until Philips can replace the PE-PUR foam sound abatement component with the new silicone foam sound abatement component. The foam has the potential to enter a device’s air pathway, causing a host of health problems and toxic carcinogenic effects for the user.Īnalysts have said that the Royal Philips (NYSE:PHG) recall may benefit respiratory care machines competitor ResMed (NYSE:RMD). There have been more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down.
FDA today designated a Philips recall of certain sleep and respiratory devices as Class I, its most serious level.ĭevices in the recall number in the millions, according to FDA’s database.
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