Philips Respironics has recalled 3,400,000 of its sleep apnea machines, also known as Continuous Positive Airway Pressure (CPAP) machines and ventilators.
The recall includes specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices to address potential health risks related to polyester-based polyurethane sound abatement foam that is in the machines. The foam used to soften the sound made by the machines can deteriorate and project tiny particles and gases that can irritate airways, cause headaches and possibly be toxic or carry cancer risks, according to the company. Philips has produced millions of devices using this foam.
The recall involves the polyester-based polyurethane sound abatement foam on these devices. The foam is meant to reduce sound and vibration while the devices are in use. As the air passes over the foam through a tube, the material may break down and then enter the device’s air pathway. Once in the pathway, black debris from this foam, as well as other chemicals, are then potentially inhaled or swallowed by the person using the sleep apnea machine. These toxic chemicals have been linked to potentially causing cancer.
The recall was announced on September 1, 2021. Repairs on affected devices, including first-generation DreamStation CPAP machines began that same month. The FDA is closely monitoring the repairs of these machines and have started on-site inspections of Philips’ manufacturing facilities to ensure that they are complying with all regulatory requirements.
Health Risks Associated with Continued Use:
Continued use of the affected Philips devices can result in respiratory issues, chest pressure, airway irritation, irritation of the eye, skin, and respiratory system, and inflammation. More serious risks include inhalation of toxic chemicals leading to cancer and potential damage to the user’s liver, kidneys, and other organs.
Potential Safety Hazards Reported:
- Philips has received complaints about the presence of black debris/particles within the device’s air pathway.
- There have also been reports of headaches, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue.
- The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.
- The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.
These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.
Details of the Recall:
The Philips Respironics recall involves the following devices manufactured between 2009 and April 26, 2021. Listed are all affected devices manufactured before April 26, 2021 and includes all device serial numbers.
This recall has been classified by the FDA as a Class I recall, meaning it is the most serious type of recall issued. Typically, Class I recalls involve products or a situation where there is a reasonable probability that using or being exposed to the product will cause serious health risks.
The product codes that are a part of this recall include the codes BZD, NOU, CBK, MNT, and MNS. Most of the affected devices are classified under product code BZD.
Anyone who used a Philips Bi-Level PAP or CPAP machine may be eligible for compensation.
Filing a Claim Against Philips Respironics:
If you have been injured by using one of these affected sleep apnea devices, you have the right to receive compensation for your injuries. Many consumers who have used a BPAP or CPAP machine through Philips Respironics are unaware that they may be entitled to financial compensation for their, medical expenses, lost wages, pain and suffering, and other damages.
The attorneys at Aronfeld Trial Lawyers are passionate about holding companies like Philips Respironics accountable when they fail to protect the health and safety of consumers who rely on their medical devices on a daily basis. Our law firm is representing individuals who utilized Philips CPAP machines and have been medically treated for lung injuries or cancer. Call our law firm today for a free consultation at 866-597-4529 or email us at firstname.lastname@example.org.
Click here for a list of CPAP and BiLevel PAP Devices that have been recalled by Philips.