On June 14, 2021, the health technology company Philips voluntarily recalled nearly twenty models of sleep apnea CPAP, BiPAP, and mechanical ventilators.
The recalled devices have a design defect causing victims to inhale dangerous particulates and toxic chemical emissions from degraded foam. This may lead to dangerous side effects, including victims developing cancer and respiratory problems.
Shouse Law Group is bringing a CPAP lawsuit against Philips on behalf of victims injured by the defective sleep apnea machines. We are pursuing the largest settlement available to cover victims’ medical expenses, lost wages, and pain and suffering.
In this article, our mass tort attorneys discuss:
- 1. Which Philips CPAP machines are being recalled?
- 2. Did the FDA issue the Philips CPAP recall?
- 3. How serious is the Philips CPAP recall?
- 4. How many Philips devices have been recalled?
- 5. What is the reason for the Philips recall?
- 6. What Philips sleep apnea devices are not recalled?
- 7. How do I know if my Philips CPAP has been recalled?
- 8. What should patients with recalled products do?
1. Which Philips CPAP machines are being recalled?
Philips recalled the following sleep apnea devices manufactured between 2019 and April 26, 2021. The recall extends to all device serial numbers for each model:
1.1. CPAPs and BiPAP devices
- C Series S/T, AVAPS (a.k.a. System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)) – continuous ventilator
- Dorma 400, 500 CPAP, Auto CPAP (not marketed in US)
- DreamStation ASV (a.k.a. DreamStation BiPAP autoSV)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP, Auto CPAP
- DreamStation ST, AVAPS (a.k.a. DreamStation BiPAP AVAPS, DreamStation BiPAP S/T)
- E30 (Emergency Use Authorization)
- OmniLab Advanced Plus
- System One 50 series CPAPs, Auto CPAP, BiPAPs
- System One 60 series CPAPs, Auto CPAP, BiPAPs
- SystemOne ASV4 (a.k.a. System One BiPAP autoSV, System One BiPAP autoSV Advanced)
Note that CPAP stands for continuous positive airway pressure, and Bi-level PAP stands for bilevel positive airway pressure.
1.2. Mechanical Ventilator Devices
- A-Series BiPAP Hybrid A30 (a.k.a. BiPAP Hybrid A30Ventilator (A-Series) (not marketed in US)
- A-Series BiPAP V30 Auto Ventilator (a.k.a. BiPAP V30 Auto Ventilator (A-Series))
- A-Series BiPAP A40 (a.k.a. BiPAP A40 Ventilator (A-Series)) (not marketed in US)
- A-Series BiPAP A30 (a.k.a. BiPAP A30 Ventilator (A-Series)) (not marketed in US)
- Garbin Plus, Aeris, LiveVent Ventilator (not marketed in US)
- Trilogy 100 Ventilators
- Trilogy 200 Ventilators1
2. Did the FDA issue the Philips CPAP recall?
No. Philips voluntarily recalled its defective CPAP, BiPAP and mechanical ventilators on June 14, 2021.2
3. How serious is the Philips CPAP recall?
The Philips CPAP device recall is classified by the FDA as class 1, which is the most serious type of recall.3
4. How many Philips devices have been recalled?
It is estimated that four million Philips CPAP, BiPAP, and mechanical ventilators have been recalled. About 300,000 of those devices were issued to veterans.4
5. What is the reason for the Philips recall?
The recalled Philips sleep apnea CPAPs, BiPAPs and mechanical ventilators have a design defect. Their polyester-based polyurethane (PE-PUR) sound abatement foam both:
- degrades into particles that patients can inhale and ingest; and
- off-gases carcinogenic or otherwise toxic chemicals that patients breathe in
This PE-PUR foam also degrades from the use of ozone cleaning methods and high heat or humidity.
This degradation of foam may cause Philips victims to develop cancer, respiratory problems such as asthma, and other health problems. Additional potential risks include:
- Nausea and vomiting
- Irritation to the eyes, skin, and respiratory tract
- Organ problems, such as with the lungs, liver and kidney
- Carcinogenic effects
Patients have also reported experiencing sinus infections, coughs, and pressure in their chests.5
6. What Philips sleep apnea devices are not recalled?
Philips devices not included in the 2021 recall are:
- A-Series Pro and EFL
- Dorma 100, Dorma 200 CPAPs (not marketed in US)
- DreamStation 2 Auto CPAP Advanced and DreamStation 2 Auto CPAP (Philips Respironics CPAP)
- Omnilab and OmniLab Advanced Titration devices
- REMStar SE and Sleep Easy C-PAP devices
- Respironics M-Series REMStar CPAPs, Auto CPAPs, BiPAP machines
- Trilogy 202
- Trilogy EV300
- Trilogy Evo
- Trilogy Evo OBM
- V60 Ventilator
- V60 Plus Ventilator
- V680 Ventilator
Also considered safe to use are Philips oxygen concentrators and products for airway clearance and respiratory drug delivery.6
7. How do I know if my Philips CPAP has been recalled?
Check to see if the sleep apnea device matches one of the recalled devices on the Philips website. Otherwise, a patient can call his/her physician.
8. What should patients with recalled products do?
Users of the recalled Philips sleep apnea devices are advised to do three things:
- Contact their healthcare provider right away to discuss when they should discontinue use and find a replacement device with another durable medical equipment (DME) provider, such as ResMed.
- Document their symptoms and preserve any evidence, such as any degraded particles from the sound abatement foam.
- Call our Shouse Law Group attorneys to discuss how we may be able to win a large financial settlement to cover all medical expenses, lost wages, and pain and suffering.
- Medical Device Recall Notification, Philips Respironics Sleep and Respiratory Care devices, Philips.
- Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, U.S. Food And Drug Administration (June 30, 2021).
- See note 2.
- Joshua Brockman, Breathing Machine Recall Over Possible Cancer Risk Leaves Millions Scrambling for Substitutes, NYTimes (August 17, 2021). See VHA National Center for Patient Safety, Philips CPAP and BiLevel PAP Recall, U.S. Department of Veterans Affairs.
- See note 2 (“The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway.”). Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices, Philips (June 14, 2021)(“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” said Frans van Houten, CEO of Royal Philips). URGENT: Medical Device Recall Philips Respironics, Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models (recall website), Philips (“To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask).”). Philips. Q1, 2021. Quarterly Report, www.Philips.com (April 26, 2021)(The foam “may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone, and certain environmental conditions involving high humidity and temperature.”)
- See note 1.