The United States Food and Drug Administration (FDA) announced a recall of reworked Philips Respironics machines due to silicone foam deterioration that, if inhaled, could cause serious illness, injury and even death.
The February 2023 recall, classified as most serious by the FDA, follows nearly two years of the health care equipment manufacturer under inspection and scrutiny.
The recall applies to Philips Trilogy 100®, Trilogy 200® and Garbin Plus® models distributed between March and September 2022 — covering a total of 13,811 machines.
These machines use a special foam, known as PE-PUR foam, to reduce sound. However, this foam can break down into possibly carcinogenic particles that can enter the device’s air path and be ingested by the user.
Swallowing this contaminated debris may also cause serious health complications, including cancer, organ damage and organ failure. A total of 82 reports of the machine’s silicone foam deteriorating have been received, and 19 consumers reported injuries from the debris.
Years of Philips CPAP Recalls and Concerns
Philips’ troubled history of mechanical ventilator recalls began in June 2021, when 15 million Philips Respironics machines were recalled. The initial recall showed foam contained within the devices could break down over time and be inhaled.
Millions of people rely on sleep aid devices, known as CPAP and BiPAP machines, to breathe safely during sleep. However, Philips executives remained negligent when they knew of the dangers in the machines but did nothing.
After a 3-month inspection, the FDA found executives knew of the foam-degradation problem long before issuing a voluntary recall.
The FDA continued to scrutinize the manufacturer for its poor handling of consumer safety. In fact, in 2022, Jeff Shuren, the FDA’s Director of the Center for Devices and Radiological Health, said the company needed to improve its communication efforts surrounding the recall since many users may not even be aware of the risks.
When Philips first announced the replacement foam it would use to rework the machines, concerns were raised. That same foam is now the cause of this year’s recall update.
Next Steps for Consumers After CPAP Recall Update
If you, or someone you love, have been using a Philips Respironics machine included in the updated recall, speak with your doctors immediately. It is not recommended to stop using the machine until health care providers can determine an alternative solution.
You may also be eligible to pursue financial compensation through a Philips CPAP lawsuit if you developed cancer or other organ damage after using a Philips sleep machine.
Contact us today to learn how Simmons Hanly Conroy may be able to help with your case.