Posts Tagged 'philips'

Philips Respiratory Devices Facing Additional Recalls

Philips respirators facing additional recallsAmid a recall that has already drawn the ire of federal regulators over the glacial pace with which it has handled remediation of the matter, Philips is facing an additional recall of some of its respiratory devices over an unrelated fault.

According to Reuters, the latest recall action targets 1,700 Philips respiratory devices around the world, with 386 of them located in the United States. The recall was issued ...

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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 ...

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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 ...

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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 ...

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SoClean Sanitizer Swept Up in Philips CPAP Lawsuits

SoClean sanitizers implicated in Philips CPAP foam injuriesShortly after the Class I recall of a number of Philips CPAP and other breathing assistance devices, a company that sells and markets a sanitization system for the devices has also been sued. Plaintiffs allege that the SoClean CPAP sanitization system uses an unsafe amount of ozone in its sanitization process. This process is alleged to contribute to and accelerate the degradation of the sound ...

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FDA Expands Recall of Philips Ventilators

fda expands recall of Philips ventilatorsMore recalls have been ordered for a variety of ventilators made by Dutch electronics and technology manufacturer Philips. The company’s troubles started in fall of last year when lines of Philips CPAPs, BiPAPs, and ventilators were recalled over concerns that the sound dampening foam used in the devices could degrade. This degradation could allow particles of the foam to enter the breathing circuits of the machines and ...

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