Philips BiPAP and CPAP Recall

Philips CPAP Breathing Machines Recalled Because of Potential Injuries

In June of 2021, Philips Respironics (Philips) recalled their continuous positive airway pressure machines (CPAP), bilevel positive airway pressure machines (also known as Bilevel PAP, BiPAP, or BPAP) and ventilators, due to potential health risks, including lung injuries and cancers. The voluntary recall announcement issued in June 2021 is a follow-up to a previous notification from April 2021. The recall involves millions of sleep apnea and ventilator devices which may increase the risk of lung injury and cancer due to inhalation of foam particles and outgassing of toxic chemicals. Philips estimates that 3 to 4 million devices may be affected, the majority of which are first-generation DreamStation products sold before April 2021.

The polyester-based polyurethane (PE-PUR) used in the machines to lessen sound and vibration can break down, and pieces of black foam or certain chemicals could be breathed in or swallowed. These issues could potentially result in serious injury. The PE-PUR foam issue may be caused by hot and humid conditions, or the use of ozone cleaners or other cleaning methods not recommended by the manufacturer.

The FDA issued recommendations for people who use recalled ventilators at home and their caregivers. They also issued recommendations regarding the recalled ventilators for health care providers and facilities. Separate recommendations were issued for people who use either the recalled BiPAP or recalled CPAP machines and their caregivers. See the list of recalled devices.

Potential Health Risks from PE-PUR Foam

If you have suffered injury or illness as a result of using a recalled Philips ventilator, CPAP or BiPAP device, or have lost a loved one because of these devices, you may be entitled to medical compensation.  Patients using the recalled Philips devices have suffered a variety of injuries including:

Respiratory:

• Lung damage
• New or worsening asthma
• Pneumonia
• Respiratory failure (such as Acute Respiratory Distress Syndrome (ARDS))
• Pleural effusion
• Reactive Airway Disease (RAD)

Cancer:

• Blood, Lymph Node, and Oral Cancers:
  • Acute Myeloid Leukemia (AML)
  • Blood Cancer
  • Bone Marrow Cancer
  • Esophageal Cancer
  • Hematopoietic Cancer
  • Laryngeal Cancer
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Nasal Cancer
  • Non-Hodgkin’s Lymphoma
  • Soft Palate Cancer
  • Sinus Cancer
  • Throat Cancer
  • Tonsil Cancer
• Thyroid Cancers:
  • Thyroid Cancer
  • Papillary Cancer
• Other Cancers:
  • Kidney Cancer
  • Liver Cancer
  • Lung Cancer
  • Bladder Cancer

Other:

• Severe ear, eye, nose, throat, sinus, oral cavity inflammation and injury including nodules, cysts, and tumors
• Sarcoidosis (particularly of the lungs and/or lymph nodes) that required treatment
• Kidney damage (acute kidney injury or chronic kidney disease)
• Liver damage (acute liver failure or chronic liver disease)

If you were injured after using a Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) or mechanical ventilator device, you may be eligible for compensation and should seek legal assistance. Our attorneys can help you determine your eligibility at no cost.

Source:

https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due

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