Amid Massive Recall, Philips Reports Issues With Some Repaired Devices

by Jennifer Henderson: For Complete Post, Click Here…

New problems affect repaired ventilators.

As Philips’ subsidiary Philips Respironics continues a sprawling repair and replacement program for 5.5 million breathing machines in the wake of a June 2021 recall mainly due to potential health risks from polyester-based polyurethane (PE-PUR) sound abatement foam, new issues are plaguing some of the repaired devices.

In mid-November, the FDA issued an update to the recall that affected certain continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines and mechanical ventilators, stating that Philips had informed the agency that reworked Philips Respironics Trilogy ventilators have two new potential issues.

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