Additional information is available on FDA’s website. The manufacturing dates are April 11, 2007–April 22, 2021, and the distribution dates are July 21, 2009–April 22, 2021. Noncontinuous ventilators including the SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto).In-facility continuous ventilator devices including the Philips Respironics E30 with humidifier.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 said it received several complaints about. They were recalled due to potential health risks related to the polyester-based polyurethane foam used in the devices to make them quieter. More than 250,000 are actually in consumers’ hands. The company further informs that it has produced around 750,000 replacement devices and repair kits. Some users will have to wait up to a year to benefit from the plan, the report continues. 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. In June, Philips Respironics announced a voluntary recall of millions of its breathing assistance machines, certain ventilators, CPAP and BiPAP machines. Philips’ quarterly report offers encouraging words that the company’s CPAP repair and replacement program is underway. 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). PE-PUR may break down and potentially enter the device’s air pathway. Affected models contain the polyester-based Polyurethane (PE-PUR) sound abatement foam used to reduce sound and vibration. There have been more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Philips Respironics issued a voluntary recall on certain CPAP, BiPAP and APAP machine models due to potential health risks.
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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