What You Need to Know About the Philips Respironics Recall

On June 14th, 2021, Philips Respironics announced that they voluntarily recalled a number of their non-invasive ventilation devices and mechanical ventilators. The Respironics recall is estimated to affect 3 to 4 million devices worldwide and over half of the devices affected by this recall are in the United States. 

If you or someone you know uses one of these devices, you probably wonder why the devices are recalled? How will the Respironics recall affect me or my loved one? What should I do if my equipment is affected by the recall?

Keep reading on to answer all of these questions and find out more about Philips Respironics recall information. 

Philips Respironics Equipment

The majority of Philips Respironics equipment recalled includes their CPAP and BiLevel PAP devices. These devices are most commonly used for people diagnosed with obstructive sleep apnea.

There are approximately 22 million Americans who suffer from obstructive sleep apnea. Many of these people rely on either CPAP or BiLevel PAP devices to breathe effectively while they are sleeping.  

Some of the devices that Respironics has recalled also include their mechanical ventilators.

Some people cannot breathe on their own wheater from an injury, disease, or various medical conditions. In these cases, a person may require a mechanical ventilator device so that they can breathe efficiently on their own. These people must use the ventilator 24/7 and cannot breathe on their own without these machines. 

A common complaint for many years with CPAP, BiLevel PAP, and some mechanical ventilator devices is the loud sound that they can make. A polyester-based polyurethane (PE-PUR) foam was added to Respironic’s devices to help reduce the sound made by these devices.

Unfortunately, the Philips Respironics recall is due to the breakdown of this foam and to chemicals produced when the foam breaks down.

PE-PUR Foam Break Down

The PE-PUR foam has been used in some Philips Respironics devices since 2009 to reduce how loud some devices for sleep apnea can be. Unfortunately, this foam can break down due to two possible factors.

One factor that can cause the foam to break down is improper cleaning of the device. The second factor is high temperatures and humidity. The high temperatures and moisture may weaken the foam and cause it to break down over time. 

Since many Respironic’s machines use heated humidified air for added comfort to patients this can be a problem for many patients. 

The foam breaks down which causes a chemical release. These chemicals then go into the breathing tubing or circuit tubing of the device. Once these chemicals get into the tubing, the person using the device breathes these harsh and potentially dangerous chemicals. 

Potential Health Concerns

Currently, Philips Respironics has not received any reports of deaths or harm to patients from the foam breakdown. However, there have been some reports of patients finding black debris in the breathing circuit tubing of their devices. 

According to Philips Respironics, the voluntary recall is out of caution due to the potentially harmful effects that the chemicals can cause, especially when inhaled. 

Some potential effects from the chemicals include:

  • Irritation to the skin, eyes, and respiratory tract 
  • Inflammatory response 
  • Headaches
  • Nausea or vomiting
  • Adverse effects to organs such as kidneys or liver
  • Carcinogenic effects 

Devices Affected From Respironics Recall

A large portion of Philips Respironics devices is unfortunately affected by this recall. Devices manufactured from 2009 to 2021 are a part of Respironics recall.  

To continue to stay up to date on Philips Respironics recall updates, be sure to check with your doctor, Durable Medical Equipment (DME) provider, and Philips Respironics site to stay up to date. The current list of effective devices are:

Continuous Ventilation Devices:

  • Trilogy 100
  • Trilogy 200
  • Garbin Plus, Aeris, LifeVent

Hospital and other facilities use devices:

  • E30

Non-life supporting continuous ventilation devices:

  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C-Series ST and AVAPS
  • OmniLab Advance +

Non-continuous ventilator devices:

  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation GO
  • Dorma 400
  • Dorma 500
  • REMstar AUTO

Devices That Are Not Affected by Respironics Recall

Several Philips Respironics devices are luckily not affected by the Respironics recall. These products are not affected because they do not use the sound-reducing foam and use other noise-reducing materials.

Another reason some of these devices are not affected is that the noise-reducing foam is located in an area of the device that cannot get into the breathing circuit. Or is in a place inside the device that is not affected by cleaning, heat, or humidity. 

Some devices that are not affected by the Respironics recall include:

  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy 202
  • EV300
  • A-Series Pro and EFL
  • M-Series
  • DreamStation 2
  • Harmony 2
  • Dorma 100
  • Dorma 200
  • REMstar SE

All Philips Respironics oxygen concentrators, respiratory drug delivery products, and airway clearance products are all safe from the recall. 

What to Do if Your Device Is Affected?

If you or someone you know has a device that is affected by the Respironics recall, it is essential to contact your doctor and DME company right away to discuss the next steps.

Philips Respironics is recommending if you have a CPAP or BiLevel PAP device used for mild or moderate obstructive sleep apnea to discontinue using the device. You should talk to your doctor about another alternative option until the recall is resolved. Your doctor may still recommend that you use the device if the benefits outweigh the risk of using the machine. 

If you or a loved one use a life-sustaining mechanical ventilator device, do not discontinue use or make changes unless specifically directed to by your physician. Fewer alternative options are available to these patients. However, in most of these cases, the risk of removing mechanical ventilation is more harmful and potentially fatal than continuing use. 

Answers to a Stressful Situation

Any time a medical equipment recall is made, it can be stressful and leave you with many questions. It is important to contact your doctor right away to find out the best solution for you in this situation if you have a device affected by this recall. 

For more information regarding sleep apnea and various devices, check out  1800 CPAP. There you will find great information and resources available to help as you navigate through available options during the current Respironics recall.    

About the Author

1800CPAP

Jason Smith is recognized by the board of polysomnographic technologists (BRPT) as a registered polysomnographic technologist (RPSGT) since 2003. He is also Director of Clinical Operations for 6 multi-state sleep diagnostic facilities including the nation’s largest 20 bed sleep disorder testing center. Jason has also been a Co-Author with two research publications featured in Journal of Clinical Sleep Medicine.