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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Patients with obstructive sleep apnea treated with positive airway therapy experienced significantly better outcomes than those not receiving the treatment, according to a new European study. After a series of setbacks, the study is positive news for sleep apnea device makers.
Royal Philips will begin this month the unenviable task of repairing and replacing millions of BiPAP, CPAP and other mechanical ventilator devices that were recalled by the manufacturer in June. The effort will take a full year, Philips says.
Calling the situation “untenable” and “unacceptable,” powerful US Sen. Richard Blumenthal has given Vitor Rocha two weeks to answer questions about Philips’ high-risk recall of certain BiPAP, CPAP, and other mechanical ventilator devices.