Langston & Lott, PLLC
Phillips Respironics Recall

Langston & Lott, PLLC Phillips Respironics Recall

Phillips Respironics Recall

Phillips Respironics Recall

The Phillips Recall

In an Earnings Report, dated April 26, 2021, Phillips Respironics announced: “we have identified a quality issue in a component that is used in certain sleep and respiratory care products, and are initiating all precautionary actions to address this issue, for which we have taken a EUR 250 million provision.” On June 14, 2021, Philips Respironics issued a recall notification for the United States for specific affected ventilation and sleep apnea devices. As of June 30, 2021, the U.S. Food and Drug Administration (FDA) began alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics recalled certain devices due to potential health risks. With the alert, the FDA classified the recall as Class I, the most serious type. The classification means there’s a reasonable probability that use of a recalled product “will cause serious adverse health consequences or death.”

The Reason for the Recall

Phillips Respironics recalled these devices because there is a polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, that breaks down or degrades allowing particulate matter and toxic gas to enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.  Because of this, users of the affected devices are advised to stop using these machines unless it is necessary for life sustaining purposes.  All users should contact their physicians for direction about continued usage or alternative therapies.

The Recalled Devices

CPAP and BiPAP Devices

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

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 (not marketed in US)
  • A-Series BiPAP V30 Auto

Continuous Ventilator, Non-life Supporting

  • A-Series BiPAP A40
  • A-Series BiPAP A30

Potential Risks and Injuries

With the PE-PUR foam breaking down, there is a risk of serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage. Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue. Some experts also believe that inhalation of the foam particulate can also cause certain types of cancer. Philips Respironics says the likelihood of foam breakdown is higher in devices that are more than three years old, those used in high heat and humidity environments (more than 95 degrees), and those that were cleaned with an ozone sterilizing device.

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 Warnings

For more than a decade, Phillips Respironics marketed their BiPAP and CPAP machines as a safe and effective treatment for sleep apnea and other respiratory issues. When first introduced, and in the ensuing years, the prescribing information and user manuals accompanying the machines contained no warnings. The Phillips Respironics BiPAP and CPAP machines were viewed as relatively safe with very few side effects or complications. It was not until June 2021, that Phillips Respironics issued a recall for their BiPAP and CPAP machines sold in the U.S. domestically. With the voluntary recall and the mounting number of lawsuits, the FDA issued its own recall and users are advised to stop using these machines and consult with their physicians. Unfortunately, the recall came too late for many patients who have already suffered severe and permanent injuries.

If you or a loved one were diagnosed with cancer or suffered from headaches, upper airway irritation, cough, chest pressure, or sinus infections after using one of the recalled Phillips Respironics BiPAP and CPAP machines, call Langston and Lott, PLLC today to speak with an experienced attorney or complete our online case evaluation by following the link above and let our law firm get to work for you.