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Philips CPAP Recall Raises Concerns for At-Home Medical Devices

Philips 2021 recall of its CPAP, BiPAP, and ventilator machines is raising awareness of the need for better communication concerning at-home medical devices. ECRI, an organization focused on healthcare technology and safety, released a list of its Top 10 Health Technology Hazards for 2023. Topping the list at number one were recalls in home-use devices. As medical technology for home use becomes more popular, the organization worries about important safety alerts reaching patients. Philips’ mishandling of its 2021 recall has contributed to the increasing concern over at-home medical devices.

Recall Process for Home-Use Devices a Major Concern

According to the ECRI, the shift to healthcare services at home is growing. However, the organization worries that patients are not receiving important safety information. Manufacturers rarely communicate with patients directly who use their devices at home. This makes the recall process for home-use devices unreliable. Patients may continue using a hazardous device and even injure themselves because they never received a recall notification. Or, sometimes communications from the manufacturer are too complex for patients to understand. So the patient may not realize that the recall applies to them or what to do next to avoid harm. 

June 2021 Recall

In 2021, Philips initiated a recall for its sleep apnea and ventilator machines. Millions used the CPAP, BiPAP, and ventilators to assist with sleeping and breathing. However, these devices contained sound abatement foam that could disintegrate over time. Patients can inhale or ingest the toxic particles, resulting in serious injury. The recall has since expanded to 5.5 million devices globally, and Philips continues to run into problems. 

Philips CPAP Recall Example of Lack of Communication

Many have criticized Philips’ failure to communicate with patients throughout the ordeal. Despite the FDA labeling the recall as a Class I, the most severe type, countless patients were unaware of the issue with their devices. 

Nine months into the recall, the FDA sent a letter to Philips, scolding the company for its poor notification activities. The agency received complaints from patients and healthcare professionals who did not know about the recall. Nearly a year into the recall, only 50% of users with the recalled products registered to receive a replacement. 

Also, the FDA contacted suppliers to test the effectiveness of Philips’ notification system. The FDA found that dozens of suppliers were not aware of the recall. This news was very troubling because if the suppliers did not know, it is likely that neither did the patients. 

Even successfully notified patients were still confused about what to do next. Philips didn’t provide clear instructions about its repair and replacement program. Over a year later, many still do not have a properly repaired or replaced device. 

The Lake Law Firm Can Help You

Philips machines and the company’s failure to inform patients put thousands of lives at risk. Individuals have filed Philips CPAP lawsuits, alleging the toxic particles gave them cancer, respiratory issues, and organ damage. If a Philips device injured you, a Philips CPAP lawyer may be able to help you file a claim. Contact The Lake Law Firm today to begin your Philips CPAP claim. 

The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 525-3529.