The U.S. Food and Drug Administration is warning consumers that Philips Respironics is recalling certain Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP) machines, which are used to treat sleep apnea. The company is also recalling some of its ventilators that are used to treat respiratory failure. The company issued the recall due to potential health risks associated with continuing to use the products. Here is what we know about the CPAP recall so far and what you can do to protect your health.
Why Is There a Recall for Philips Respironics ventilator?
The Philips Respironics ventilator recall was spurred by customer complaints about black debris or particles within the device’s air pathway. This debris is formed when the device’s polyester-based polyurethane sound abatement foam breaks down or degrades into the device’s air pathway. This can cause the device’s user to inhale or swallow these dangerous particles, which can result in serious injury. Without medical intervention, these issues can cause permanent impairment and be life-threatening. The FDA says that potential risks to exposure to these particles can include:
- Toxic or carcinogenic effects on organs
- Irritation in the respiratory tract
- Inflammatory response
- Skin and eye irritation
High heat and high humidity environments can increase the degradation of the polyester-based polyurethane foam.
What Devices Are Involved in This Recall?
The Philips Respironics CPAP, BiPAP, and ventilators affected by the recall were manufactured between 2009 and April 26, 2021. They include the following models:
CPAP and BiPAP Devices
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use – E30
- Continuous Ventilator, Non-life Supporting – DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T, and AVAPS, OmniLab Advanced+
- Noncontinuous ventilator – SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto
- Continuous Ventilator – Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use – A-Series BiPAP Hybrid A30, A-Series BiPAP V30 Auto
- Continuous Ventilator, Non-life Supporting – A-Series BiPAP A40, A-Series BiPAP A30
Links to Lung Cancer
It is believed that the particulates that become dislodged and are swallowed or inhaled can increase a user’s risk of lung and other cancers as well as pulmonary fibrosis. When these particulates are inhaled or ingested, they may emit volatile organic compounds that can result in adverse effects to organs, including cancer. Cases regarding these alleged injuries are currently being filed in multiple jurisdictions.
What to Do If You Have an Affected CPAP Machine
If you are currently using one of the affected machines, the FDA encourages you to speak to your healthcare provider. You may experience adverse health effects if you suddenly stop using a machine you have been prescribed. You may be able to use a replacement device or alternative treatments.
How We Can Help
If you have suffered injuries by using one of these devices or would like more information on the current FDA recalls, we can help. The experienced trial attorneys at Eisenberg, Rothweiler, Winkler, Eisenberg & Jeck, P.C. can evaluate the circumstances and determine if you have a claim for compensation.
Contact us for your free consultation.