Vindication, Or Spin? Philips Says Tests Confirm Safety Of Breathing Machines. Plaintiff Attorneys Argue Results Lack Credibility
Royal Philips says independent tests show its sleep therapy devices, which have been the subject of controversy since being recalled in June 2021, are safe and unlikely to harm patients. Attorneys representing patients suing the company call the results a shameless attempt to deflect blame.
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Philips Implements Plan To Address FDA Concerns Following Harsh Inspection Report
After a lengthy inspection of a Philips facility that manufactured several recalled breathing and ventilator devices, the US Food and Drug Administration delivered a pointed report to the company highlighting multiple risk management and quality systems issues. In response, Philips wrote to the FDA outlining steps it plans to take to fix the problems.
FDA Orders Philips To Bolster Communications Around Recalled Breathing Machines, Calls Notification Efforts ‘Inadequate’
The US FDA on 10 March sent a letter to Philips Respironics that orders the company to beef up its recall communications, among other directives. The agency is worried about what it perceives as the firm’s lackluster notification activities around the June 2021 recall of millions of BiPAP, CPAP, and other mechanical ventilator devices.
Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices
Royal Philips has been reeling from a June recall of millions of breathing machines, and now it’s been slapped by the US FDA with multiple observations after an on-site inspection. One observation says the company didn’t open formal investigations after receiving hundreds of thousands of complaints of particles and other contaminants when the recalled devices were used.