Philips Respironics CPAP, BiPAP & Ventilator Recall

Philips Respironics Recall

Pope McGlamry is investigating claims of injuries related to use of Philips Respironics CPAP, Bi-level PAP (BiPAP), and other Philips assisted breathing devices. Pope McGlamry has spent decades litigating against large companies like Philips, for the manufacture and sale of faulty or dangerous products, including numerous medical devices. Thus, Pope McGlamry’s attorneys have the knowledge and experience to successfully represent patients who have been impacted by the use of Philips’ recalled breathing machines. If you or a loved one used a Philips recalled device and were later diagnosed with lung cancer, kidney cancer, liver cancer, kidney failure, liver failure, or COPD, please contact our experienced attorneys for a free consultation.

Reason for the Philips BiPAP and CPAP Recall

On June 14, 2021, Philips announced an “Urgent: Medical Device Recall” of millions of units of the Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. Many of the products included in the recall are DreamStation products, used to treat sleep apnea. Philips estimates that there are 3-4 million devices that could be affected. The defect is related to the polyester-based polyurethane (PE-PUR) sound abatement foam in the devices. The foam may disintegrate or degrade and potentially enter the device’s air pathway, resulting in the user inhaling contaminants or toxic chemicals.

What are the Dangers of Philips CPAP and BiPAP Machines?

The use of certain cleaning materials or use of these devices in environments with high heat and humidity may contribute to the breakdown of the foam. Inhalation of these contaminants may cause liver or kidney failure; liver, kidney or lung cancer, or other respiratory issues such as COPD. There have been more than 1,200 complaints and more than 100 injuries reported for this issue. Even if there are no visible particles, the foam may already be breaking down and releasing harmful chemicals. Philips’ lab analysis found the degraded PE-PUR Foam produced several potentially harmful chemicals including:

Toluene diamine: Compound used to make polyurethane, dyes, hydraulic fluid and sensitizers for explosives. Health hazards include: genetic defects, skin reactions, toxicity, cancer, damaged fertility and organ damage.
Toluene diisocyanate: Liquid for making foams and coatings. Health hazards include: cancer, eye damage, skin irritation, respiratory irritation and may be fatal if inhaled.
Diethylene glycol: Solvent used in the manufacturing of other chemicals that can irritate skin, eyes and mucous membranes and may be slightly toxic if swallowed.
Dimethyl diazene: Gas used to create other chemicals.
Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl): Another gas used in the production of other chemicals.

Next Steps for Philips Sleep Apnea Machine Users

At this time, Philips’ recall announcement advises users of the affected Bi-level PAP and CPAP devices to discontinue use and consult with their physicians regarding the potential benefits versus risks. For patients using life-sustaining mechanical ventilator devices, the company has recommended these users do not discontinue use of the device without first consulting their physician. Philips is notifying customers that it will replace affected devices that are still under warranty, although no timeline has been provided to alert customers as to when this may occur. Please seek the advice of a medical professional before making health care decisions.

Philips Recall List: Sleep Apnea Machines & Ventilators

Recalled Devices[1]:

The Recalled Devices affect all serial numbers of the following affected devices manufactured between April 11, 2007 to April 22, 2021:

CPAP and BiPAP Devices
- E30 (Emergency Use Authorization)
- 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

Ventilators
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
- A-Series BiPAP Hybrid A30 (not marketed in US)
- A-Series BiPAP V30 Auto
- A-Series BiPAP A40
- A-Series BiPAP A30

[1] Recalled devices as of Philips’ June 14th, 2021 recall notice.

Philips Respironics Recall

Reason for the Philips BiPAP and CPAP Recall

What are the Dangers of Philips CPAP and BiPAP Machines?

Next Steps for Philips Sleep Apnea Machine Users

Philips Recall List: Sleep Apnea Machines & Ventilators

Contact Our Philips Respironics Recall Attorneys