Some 24 million Americans who use certain models of Philips breathing machines are searching for new equipment in the wake of a company recall due to the products’ potential cancer risks.
The recall, which also includes ventilators made before April 26, includes a dozen types of the CPAP and BiLevel PAP devices that help people with sleep disorders, breathing problems and respiratory emergencies.
Earlier this summer, the USFDA said the recalled machines posed risks that could be “life-threatening, cause permanent impairment and require medical intervention.” The FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall.
Source of the Problem
Polyester-based polyurethane foam that reduces sound and vibration in the machines can break down and result in users breathing in chemicals or swallowing or inhaling black debris that can lead to asthma, skin and respiratory tract irritation and “toxic and carcinogenic effects” to organs including the kidneys and liver.
The FDA ordered Philips to submit a repair-and-replacement program for the faulty components. In addition, Philips must conduct extensive testing and provide results to the FDA for review before the sleep therapy devices can be sent to consumers.
Working on a Solution
According to the New York Times, Philips is said to be working “expeditiously” but is “not able to provide an immediate solution.” The company is already producing repair kits of about 55,000 units a week that have not yet been approved for shipping.
Smith LaCien LLP is investigating claims since the machines have been associated with harm to users. Users have been forced to replace the expensive machines through no fault of their own.