It’s Class I For June Recall Of Philips Breathing And Ventilator Devices
The US FDA on 22 July designated a recent recall by Royal Philips of certain bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices as high-risk class I.
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News We’re Watching: Philips And Walgreens Settlements, ReCor Readies For Takeoff, Farapulse Trial Results
This week, Philips announced a legal settlement on recalled CPAPs and BiPAPs; the FDA released emergency preparation recommendations; ReCor prepared to bring Paradise RDN to the US market; and Abbott released the results of a trial comparing optical coherence tomography (OCT) to angiography for guidance during cardiac surgery.
Philips recalled thousands of Trilogy Evo ventilators in March. The US FDA has designated the recall class I, its most serious type.
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.