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
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 ...
FDA Expands Recall of Philips Ventilators
Posted February 9, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
More 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 ...
As 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 ...
