In June of 2021, the manufacturer Philips issued a recall for many respiratory aids, including CPAP machines and ventilators. While this recall was voluntary, the Food and Drug Administration (FDA) has issued warnings regarding the use of these devices. There is a list of recalled Philips CPAP machines and ventilators.
In total, there are more than a dozen devices Philips has recalled due to potential health risks associated with their use. If you have used any of these devices, you could face health issues due to the defects within the device’s design. Review this list of recalled Philips CPAP machines and ventilators
Models of Philips CPAP Machines and Ventilators That Have Been Recalled
The list of recalled Philips devices includes more than 15 individual products. Some of these devices are CPAP machines, while others are mechanical ventilators. Despite the differences between these devices, the reasons for the recall are the same.
CPAP and BiLevel PAP Devices
In total, Philips has recalled 12 different CPAP and BiLevel PAP devices. These include continuous and non-continuous ventilators.
- DreamStation ASV
- DreamStation ST
- SystemOne ASV4
- C Series S/T
- OmniLab Advanced Plus
- System One 50 Series
- System One 60 Series
- DreamStation CPAP
- DreamStation GO CPAP
- Dorma 400
- Dorma 500
Philips has also recalled many mechanical ventilators. Of the seven ventilators in total that the company recalled, three are known as continuous ventilators. A continuous ventilator is a device that breathes for a patient mechanically based on different variables. The remaining ventilators on the list are either in facilities or used for non-life sustaining purposes. Recalled ventilators include:
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, and LifeVent Ventilator
- A-Series BiPap Hybrid A30
- A-Series BiPAP V30 Auto Ventilator
- A-Series BiPAP A40
- A-Series BiPAP A30
Philips Products Not Impacted By the Recall
Not all Philips CPAP machines and ventilators have been recalled. Some of these devices relied on other sound abatement material types that have not been linked to dangerous health consequences. Some of the devices not included in the recall include:
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- A-Series Pro and EFL
- Respironics M-Series REMStar CPAPs, Auto CPAPs, BiPAPs
- DreamStation 2 Auto CPAP Advanced and DreamStation 2 Auto CPAP
- Omnilab and OmniLab Advanced Titration devices
- V60 Ventilator
- V60 Plus Ventilator
- V680 Ventilator
- REMStar SE and Sleep Easy CPAP Machines
- Dorma 100, Dorma 200 CPAP Machines
Philips CPAP Recall History
On June 14, 2021, Philips issued recall notices for several CPAP, BiPAP, and mechanical ventilator devices. Although this recall was technically voluntary, Philips did so in compliance with recommendations made by the FDA.
Starting immediately upon the issuance of the notice, Philips set up a device registry with the manufacturer for users to seek replacement or repair of their devices. In total, the company recalled between three and four million devices.
Philips Took Some Measures to Repair Devices, But Never Fully Solved the Issue
Following the recall announcement, the FDA began inspecting manufacturing facilities operated by Philips to pinpoint any contributing factors regarding the dangerous foam used in these devices.
In September 2021, Philips began replacing the foam within the recalled devices to address the identified safety issues. The FDA recommends users speak with their doctors to determine a course of action during the recall.
Understanding the Problems with Philips CPAP and Ventilator Devices
The Philips recall is due to many serious health consequences reportedly tied to the use of these devices. The use of these devices has been linked to both short- and long-term health consequences largely related to respiratory issues. This is especially difficult for many patients required to use these devices due to a history of prior respiratory issues.
Philips CPAPs and Ventilators Have Foam That Degrades and Causes Health Issues
The issue with these CPAP and ventilator devices centers on the foam used to lessen the devices’ sound. This foam is constructed from polyester-based polyurethane, also known as PE-PUR.
According to recall documents, the foam used in these devices has reportedly begun to break down with frequent use. There is also evidence that high heat and unapproved cleaning agents have increased the speed at which this substance breaks down.
The degradation of the PE-PUR foam has resulted in users of Philips devices inhaling fibers. These fibers have caused many health issues, especially in cases of extended use.
What Health Issues are Linked to Use of Philips Devices Using PE-PUR Foam?
Some of the health consequences related to using these devices are short-term and do not represent a risk of permanent health consequences. That does not mean these conditions are minor, as they could lead to painful or uncomfortable irritation and inflammation of the nose, throat, or lungs.
The most serious health issues tied to the recall of these devices are related to cancer diagnosis. The carcinogenic effects of these fibers can potentially impact the lungs, liver, or kidneys.
In addition to cancer, there are also reports of CPAP use being linked to skin irritation, respiratory issues, or even asthma. Medical intervention and long-term treatment could be necessary for some individuals following extended exposure to these fibers.
Talk to an Attorney If You Have Used One of These Devices
If you are unsure if the Philips recall applies to a device you have used in recent years, you can take steps to determine if you are entitled to compensation. The first step involves reviewing the list of recalled Philips CPAP machines and ventilators to determine if you have been exposed to dangerous PE-PUR fibers or debris.
Once you determine you have used one of the recalled devices, the next step is to seek out legal counsel. Chalik & Chalik Injury Lawyers believes you deserve to hold the makers of these devices accountable for their dangerous design. Call (855) 529-0269 for a free consultation about how Philips could be liable for your losses.