Philip’s Problems Rise As FDA Categorizes its Expanded Ventilator Recall as Class I Event

FDA added the ventilators to the Recall. Its first phase began in June, 2021.The FDA stated that the expanded Recallcovers 51 Trilogy Evo repair kits and 215 Trilogy Evo ventilators. The Philips needs to replace these ventilators. FDA added the ventilators to the list following the discovery stating that the foam at the heart of the original Recall was used to manufacturing some Trilogy Evo ventilators.

The Philips Recall is focused on respiratory devices like ventilators that feature polyester-based polyurethane (PE-PUR) sound abatement foam. The FDA said that the foam is associated with negative health impacts. Initially, Philips has asserted that the Trilogy Evo ventilators do not contain foam. However, new knowledge says that the Trilogy Evo ventilators contain foam that may have health risks.

FDA stated listing the ventilators said that Philips used the foam incorrectly in Trilogy Evo ventilators. During the use it was found that it releases polyester-based polyurethane (PE-PUR). But the affected devices were already supplied to the customers in Korea and US.

Taking note of it, Philips in a mail had said that, it has reached to the affected customers and will resolve the problem in next few months. FDA noting the incorrect use of the foam enlisted the Trilogy Evo ventilators in class I event. While no users of the Trilogy Evo ventilators have been affected or reported deaths the Trilogy Evo ventilators are said to cause respiratory problems.