According to a news article posted on reuters.com, the U.S. Food and Drug Administration (FDA) announced an expanded recall affecting Philips ventilators on January 26, 2022. The recall is also classified as Class 1 recall due to the potential for injury or death. Class I recalls are the most severe type of FDA recall. Philips […]
Philips Expands Class I Ventilator Recall
According to a news article posted on reuters.com, the U.S. Food and Drug Administration (FDA) announced an expanded recall affecting Philips ventilators on January 26, 2022. The recall is also classified as Class 1 recall due to the potential for injury or death. Class I recalls are the most severe type of FDA recall.
Philips is a Dutch medical equipment company that manufactures many different types of consumer products. The company initiated a recall of its 215 Trilogy Evo ventilators as well as 51 repair kits. The recall only affects units sold in the United States. The recall also described several potential health risks from sound abatement foam used on the devices.
According to the recall and news reports, there are no reports of deaths or injuries connected to the product recall.
A Philips spokesperson stated that the company had already connected with most of the affected customers, and the company was correcting the hazard.
This is the most recent Class I recall by Philips concerning their breathing-aid machines. Last year, the company recalled more than 4 million breathing machines because the polyurethane foam used on the breathing devices degrades and exudes toxic fumes and particles.
Earlier this month, Philips raised that number by another million units.
The recall alleges that one Philips supplier incorrectly used the wrong kind of polyurethane foam on one model of Trilogy Evo ventilators. That supplier The supplier allegedly used polyester-based polyurethane foam and not the FDA-approved polyether-based foam. The polyester-based foam has been shown to break down, and the chemicals can enter the device user’s mouth, nose, throat, and lungs.
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