Polyurethane Foam Problems Nudge Philips To Recall Certain Sleep, Mechanical Ventilator Devices
Sound abatement foam used in particular bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices made by Royal Philips could degrade, posing a risk to patients.
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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.
Another Headache For Philips As Company Recalls Millions Of Sleeping Masks
The US FDA says a Philips recall of more than 17 million masks worn with some recalled breathing machines raises further safety concerns about other medical devices manufactured by the company.
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.