New information out of the Food and Drug Administration related to the ongoing recall of various models of Philips respiratory aids was very bad news for the company. In two updates released just days apart, the federal agency indicated that not only had the number of reports received over breakdowns in the foam used to insulate the mechanics of the devices crested 20,000 in just one quarter, but that ...
When it Comes to Philips Respirators, There’s Bad News and Worse News
Posted December 30, 2022 in Product Liability | Product News and Recalls
Amid 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 ...
continue reading...FDA: Philips Ventilator Foam Killed Over 100
Posted June 9, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
As 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 ...
Philips Threatened with Massive Refunds as FDA Grows Impatient Over Respiratory Devices
Posted May 31, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
The 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 ...
Citing 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 ...
continue reading...SoClean Sanitizer Swept Up in Philips CPAP Lawsuits
Posted March 8, 2022 in Drug and Medical Device Lawsuits
Shortly 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 ...
