The Dutch healthcare company, Philips, recalled one of its products, a CPAP machine, in June of 2021 but the FDA is still unsatisfied about how the company has managed the situation of the recall as its shares fell by 9.6 percent in Amsterdam.
In 2021, the recall consisted of Philips recalling millions as a Class 1 issue of its CPAP machines and Bipap Ventilators used to treat sleep apnea. The recall occurred due to the company finding abetment foam that could get into the airways of the machines and potentially lead to cancer.
Philips has already stated it would allocate $1.1 billion as a means to address the recall for 5.5 million devices. The company will also proceed to pay a minimum $479 million to settle certain legal disputes. (1)
With this, the FDA has continually received over 100,000 complaint reports and 385 deaths. However, even after two years, the healthcare company continues to repair its devices as the FDA is still not satisfied with the additional testing and data to support the machine is safe to use.
“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” the FDA said in a published update on the situation. (2)
Following this, Philips responded by stating the company has conducted five laboratory tests on the devices, but has agreed to conduct studies as safety is one of its top priorities.
“Philips’ first priority is the health and well-being of patients, both in terms of providing replacement devices and testing to seek more clarity on the safety of the sleep and respiratory care devices under the recall,” it said in a Reuters article.
Even though Philips continues to focus on creating a better device for the safety of its customers, this recall has taken a toll on the company within the CPAP and respiratory device market, making it fall far behind its competitors in the market.
For example, as Philips products continue to be recalled, other CPAP machine and respiratory companies, such as Resmed, have reached a revenue of $3.58 million in 2022.
Although the company is in the stage of continuing more tests on devices, the Chief Executive Officer of Philips, Roy Jakobs, said the company will continue to grapple with this loss for seven more years.
As of now, Philips is working alongside the FDA to agree on a potential consent decree. This decree might require Philips to temporarily stop certain operations in the United States until it has successfully made the product safe for consumers.
With the current situation, the FDA has added an additional section on its site that provides a timeline for future steps and feedback from patients.
For more information and to keep up to date on the Philips recall, check out our comprehensive article.
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