Posts Tagged 'ventilator'

FDA: Philips Ventilator Foam Killed Over 100

fda releases numbers on Philips foam death tollAs patients wait for Philips to take action on the sound-deadening foam used in the manufacture of tens of thousands of ventilators and other respiratory devices, 124 have died and over 21,000 complaints of adverse reactions have been received over exposure to the substance. The Food and Drug Administration recently released the updated numbers as Philips continues to drag its feet on informing the public of ...

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Philips Threatened with Massive Refunds as FDA Grows Impatient Over Respiratory Devices

Philips threatened with massive refunds over respiratory aid device foam issueThe FDA is not happy with the pace of Philips’ response to an issue with multiple lines of respiratory devices. The corporation recalled millions of the devices almost a year ago and has yet to provide customers at home and at hospitals with a plan to replace the machines that, according to the recall, could be sending carcinogenic foam particles into their lungs and increasing their risk ...

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FDA Issues Order Over Philips Recall Communication

fda tells Philips to work harder on ventilator recall notificationCiting a need for improvement in the way Philips has handled its duty to notify patients of the recall of a variety of its ventilators and breathing aids, the FDA issued an order to the corporation earlier this month mandating a more open flow of information.

In a statement on the agency’s website, the director of its Center for Devices and Radiological Health acknowledged the ...

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Philips Ventilator Recall Sees Class I Status from FDA

philips breathing machines recalledAs the delta variant of the COVID-19 pandemic sweeps through largely unvaccinated swaths of populations around the world, certain Philips ventilators and other breathing apparatuses have been pulled from service for a failure to function properly. The severity of the failure has earned the recall a Class I status from the U.S. Food and Drug Administration which is reserved only for the direst of circumstances where continued use of the ...

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Philips Device Recall Expands with Cancer Risk Warnings

philips breathing machines may be linked to cancerAs electronics manufacturer Philips struggles to cope with its second medical device recall of the year, the news regarding its first recall has just gotten significantly worse. Earlier this year, a variety of Philips ventilators, BiPAP, and CPAP machines were taken out of service and recalled over concerns that the sound-deadening foam used to insulate the machines and make them quieter could enter the breathing circuit and allow particles ...

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