Philips: It Will Take 12 Months To Repair And Replace Recalled Sleep, Ventilator Devices
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.
You may also be interested in...
A silicone foam that replaced hazardous polyurethane in some reworked Philips Trilogy ventilators could separate from the unit and block air flow; additionally, particles have been found in ventilator air pathways.
The US FDA is weighing whether to force the embattled company to repair, replace or refund recalled BiPAP, CPAP and other mechanical ventilator devices. Philips Respironics may attend an “informal hearing” before the agency decides.
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.