Phillips Respironics – CPAP Recall

Phillips Respironics – CPAP Recall

On June 14, 2021, Philips Respironics issued a recall notification because of potential health risks associated with the polyester-based polyurethane (PE-PUR) sound reduction foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, as well as certain mechanical ventilators. Philips acknowledged that the PE-PUR foam may degrade or fall apart into tiny black particles that can enter the device’s humidifier, tubing and mask and be ingested or inhaled by the user. Testing by Philips also found that the foam can produce unsafe chemical levels that are released as gases.

The particulate and off-gas chemical exposure can result in serious injury which can be life-threatening, cause permanent impairment, or require medical intervention to prevent permanent injury. Philips admits to receiving complaints regarding the presence of black debris/particles within the “airpath circuit” which extends from the device outlet, humidifier, tubing, and mask. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Potential risks of particulate exposure include irritation to the respiratory tract, inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects. The potential risks of chemical exposure due to off-gassing include headache/dizziness, respiratory tract irritation, hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. According to Philips, there have been no reports of death as a result of these issues.

The following CPAP and Bi-Level PAP Devices have been recalled:

(All Devices manufactured before April 26, 2021. All serial numbers.)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

• E30 (Emergency Use Authorization)

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

The following mechanical ventilators have been recalled:

(All Devices manufactured before April 26, 2021. All serial numbers.)

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

 

If you have been affected by the Phillips Respironics CPAP recall, you should take the following steps immediately:

1) Submit a claim for device repair or replacement through Philips’ registration process at https://www.philipssrcupdate.expertinquiry.com/?ulang=en.

2) Explore your legal rights and potential personal injury claim by contacting Meshesher & Spence through the website or calling 1-888-632-3495.

News and Resources

News and Resources:

• Visit the Philips recall webpage for current information.
• Use the Philips registration process to look up your device serial number.
• Watch the recording of the panel discussion about the impact of the recall on vulnerable populations (6/25/21)
• View the AASM guidance in response to Philips recall of PAP devices (6/19/21)
• View the Philips PAP device recall guidance for patients (6/19/21)
• Watch the recording of the Philips PAP recall panel discussion (6/18/21)

 

If you or a loved one received a recall letter from Philips Respironics or the company from which you purchased your CPAP or Bi-Level PAP Device, please contact Meshbesher & Spence for a free consultation.

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