On June 14th, 2021, Philips Respironics released a safety communication statement that they will be issuing a device recall for almost all of their machines sold from 2009 to the present day. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. The recall includes many mechanical ventilator devices, BiPAP (bilevel positive airway pressure), APAP (automatic positive airway pressure), and Philips Respironics CPAP machines (continuous positive airway pressure) used for sleep apnea though there are some exceptions and devices that do not fall under the recall notification. People using ventilator devices as well as ASV medical devices were told not to discontinue use and to speak to their healthcare professional. Travel CPAP devices such as the Dreamstation Go are also affected.
They additionally state that Philips Respironics understands the full gravity of the matter and how they are inconveniencing their customers this way. However, they are treating the recall as their current biggest priority and will do everything to provide the customers with adequate service to either replace to repair this medical equipment.
This includes manufacturing, repairing, and supplying their product worldwide and other necessary actions needed to appease customers.
This brings the question of what brought about the need for a recall in the first place. Let’s find out.
What was the need for a voluntary recall from Philips Respironics?
Almost all of Philips Respironics’ older medicaldevices have the sound abatement foam PE-PUR on bipap devices and CPAP devices. It has been suggested that this kind of foam can disintegrate and turn into mini particles and create black debris. These particles might somehow make their way into the airway of the patient. The patient might end up breathing in or digesting the particles. This foam can also cause certain chemical reactions that may have carcinogenic effects.
If the BiPAP machines and CPAP machines are cleaned by cleaningmethods that are not recommended like the use of ozone, it might also accelerate foam degradation. If the device is in an environment where the overall weather is humid and or experiences high heat it can cause further foam degradation. Continuous ventilators like the Trilogy 100 and 200 are also recalled devices under this recall notice.
What are the potential health risks of the degraded foam?
Previously, Philips Respironics has received several complaints about the airway in the devices being invaded by black debris. The patients have also complained about feeling irritation in the upper respiratory tract, experiencing chest pains, and coughing a lot. The patients also seem to suffer from sinus infections and headaches.
This falls in line with what could happen if the patient ingests foam particles. The risks from this have been a rapid worsening of liver and kidneys, asthma, headaches, irritation in the eye, skin, and nose. The patient could also experience inflammation in different parts of the body.
If the patient were to be exposed to the chemical emission caused by the foam, the patient could feel nauseous, feel dizzy and feel itchy in the nose, eyes, and skin.
The good part about this is that despite having several complaints, the patients appeared not to have received long-term, serious harm of any kind. Furthermore, as Philips Respironics would recall all the products with the PE-PUR foam, it can be concluded that patients would not be harmed in the future either.
Is this an official recall from the company?
Philips Respironics has chosen to follow through with a voluntary recall. In the US, they have issued a notification asking customers to register their device for the recall if eligible. On the international base, a notice for field safety has been released for now. The FDA (Food and Drug Administration) has been working with Philips to provide a solution to customers. This is a classi recall-the most serious type of recall classification .
As of now, Philips Respironics would be calmly conducting the recall by adhering to the previous requirements and steps suggested while making a recall by a company.
Which products from Philips Respironics are not facing recall?
The products Philips Respironics have excluded from the recall appear to have different foam substances for abating the sound. Over time, as the technology and material have changed, so have been the ones used for the newer products. The design of the device could also play a role in why the devices weren’t impacted, such as the sound abating foam being placed in a different location.
As such, the list of products that have not been recalled are:
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- A-Series Pro and EFL
- Respironics M-Series REMStar CPAPs, Auto CPAPs, BiPAPs
- DreamStation 2 Auto CPAP Advanced and DreamStation 2 Auto CPAP
- Omnilab and OmniLab Advanced Titration devices
- V60 Ventilator
- V60 Plus Ventilator
- V680 Ventilator
- REMStarSE and Sleep Easy CPAPs
- Dorma 100, Dorma 200 CPAPs (not marketed in US)
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
How to get information on whether your CPAP product has been recalled?
The easiest way to be certain whether your CPAP product is part of the recall is to get your machine registered on the recall website. While registering, Philips will let you know if your device is affected by the recall or not.
To get your machine registered on the website:
1. Find the CPAP machine’s serial number
On the bottom of the CPAP machine, you will find a couple of numbers and letters. It will be beside the letters S/N or SN.
2. Visit the recall website
This is thePhilips Respironics recall space. You will find a list with names of affected devices along with a form asking for your job identity and country. Complete the information required by the website.
3. Wait to receive the confirmation
If your machine is part of the recall, Philips Respironics will provide a confirmation number for registration to you. Along with it, you will get multiple updates on how the recall is going. Note down the confirmation number, and you will find Philips Respironics providing you with information on what to do next.
If your machine is not part of the recall, a message will flash on the screen informing you the device does not count.
How will this entire issue be fixed by Philips Respironics?
The simple way Philips Respironics will be dealing with this issue is to replace the sound abatement foam. Instead of the PE-PUR foam, they would be using foam materials that do not disintegrate. However, to do so, some hurdles have to be passed as there are protocols for recall.
For now, the agencies that deal with recalls have been given all the information necessary. A third-party vendor will coordinate to make the recall go as smoothly as possible.
How long would it take before the recall is complete?
According to the Chief Executive of Philips Respironics, the entire company will focus on taking these units back, replacing the foam, and repairing them. However, it is predicted that at least a year would pass before the recall can be called successful despite such sincerity.
As they are directing all their energy on the recall, new customers would not be getting any service for now. Unfortunately, this means there would be a shortage of new Philips Respironics products in the market, except for those already manufactured.
Why would it take a year?
Several factors are affecting the recall. The following are the reasons why it would take a year:
Philips Respironics is a huge company that has services millions of customers over the year. An estimation of 4 million units has been provided that would have to be recalled. Getting the machines back in itself would take lots of time. If we add to that the time it would take to repair and replace the parts, it is inevitable that the recall would take more than a year.
Shortage of software chips globally
Fire, trade wars, and the pandemic have affected the overall supply of software chips globally. The machines from Philips Respironics use these software chips on a lot of their machines. A widespread shortage means the supplies for these machines would be lower, too, so Philips can’t easily access these software chips. On the other hand, these chips are essential components of the machines, so they can not do without them either.
Several factors have affected how shipments are being conducted in the US. Additionally, the shipping price has increased, and cargo ships do not have many spots on them. This also extends the time length it would take to get the recalled machines.
No customer would be happy about the Philips Respironics recall. This is a given. It can be a frustrating and worrying thing to deal with on your end. However, this recall does allow you the opportunity to replace your machine parts and the machines. You can search for equipment that is best suited for you. In general, it is never a good idea to hold on to CPAP, BiPAP, or APAP parts for too long. It has always been recommended that you replace them from time to time. Please visit the Philips.com website for updates on the Philips recall and to find the phone number you can call to find out information on your CPAP/BiPAP pap devices.
If you liked your overall experience with Philips Respironics, you might want to purchase replacement devices like the Dreamstation 2 products, such as the DreamStation 2 Auto CPAP Advanced with Humidifier. You might also want to switch to AirSense 10 AutoSet with HumidAir CPAP Machine from ResMed.
Since these are medical expenses, your insurance company might be able to offer you some relief on expenses. You can also purchase these products directly if you so prefer.
How serious is the Philips Respironics recall? ›
The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.Should I still use my CPAP with the recall? ›
If you're using one of the machines that has been recalled by the FDA, you might think that you need to immediately stop using it, but that might not be helpful for your sleep apnea. As advised by the FDA, you shouldn't stop using your CPAP device just because it's listed in the recall.What is the latest update on the Philips CPAP lawsuit? ›
January 10, 2023 Update: The MDL continues to move forward. The judge issued a new order last week governing electronic discovery. January 4, 2023 Update: One of the last CPAP recall lawsuits to get filed in 2022 was the case of Braverman v. Koninklike Philips N.V. (22-cv-7927).How do I get my Philips CPAP machine replaced? ›
Replacing Your CPAP Device
To have your existing DreamStation repaired or replaced under warranty, contact Philips at https://www.philipssrcupdate.expertinquiry.com/ or call 877-907-7508.
Home » FAQs » Should I Stop Using My Philips CPAP Machine? Even though the U.S. Food & Drug Administration (FDA) recalled many Philips CPAP machines, you shouldn't stop using yours until you talk to a doctor. A healthcare professional can give more information about whether using your CPAP machine is safe.Should I be worried about the CPAP recall? ›
Yes. The risks of not using your CPAP or BiPAP machine may outweigh the risks associated with the recall. Your physician should be made aware of any risks this recall could pose to you and may advise continued use of a Philips device even if it's been recalled.Is Philips going to replace recalled CPAP machines? ›
On 12/07/2021, Philips confirmed that they are performing the repairs/replacements for the affected recalled CPAPs.What is the status of the CPAP recall? ›
The health risks come from sound abatement foam used to keep the machines quiet and reduce vibration. In July 2021, the FDA classified the Philips CPAP recall as a Class I recall. This means the recalled product may cause serious injury or death.When should I stop using CPAP? ›
As long as you have sleep apnea, you will continue to need to use CPAP therapy. That being said, you can discontinue the use of your CPAP machine if your sleep apnea becomes cured or enters remission.What is happening to the CPAP lawsuit? ›
New CPAP Lawsuit Updates
The MDL was assigned to Senior U.S. District Judge Joy Flowers Conti. It encompasses several hundred cases. Other lawsuits filed in other courts are likely to be transferred, too. In September 2022, Phillips settled a claim made by the U.S. government that it was paying illegal kickbacks.
Can I get a refund on my Phillips CPAP machine? ›
Call (855) 529-0269 today so we can get to work on your case. You may be able to get your money back for your CPAP, but if you have sustained injury from using your machine, you might also be eligible to recover compensation from Philips Respironics.Have there been any CPAP settlements? ›
There have not been any reported settlements involving defective CPAP lawsuits against Philips. This litigation is in the primary states, and our CPAP lawyers don't expect any apnea machine cases to be resolved for some time. However, these cases can potentially drive substantial Philips CPAP lawsuit settlement values.How much is the CPAP lawsuit worth? ›
CPAP Class Action Lawsuit
Based on prior global settlements in similar mass torts, our CPAP lawyers think that the likely settlement payout on Philips CPAP claims will be $150,000 to $250,000 for cases in the highest settlement tier and $75,000 to $150,000 for cases in the next tier down.
Medicare pays the supplier to rent a CPAP machine for 13 months if you've been using it without interruption. After Medicare makes rental payments for 13 continuous months, you'll own the machine.How do I return Philips Respironics? ›
Find the closest drop off location or schedule a pickup. You may also give the package to any FedEx driver making regular pick ups or deliveries or take the package to an authorized FedEx shipping outlet. This return shipment is pre-paid, so there is no charge to you. Thank you for your cooperation in this effort.How does a CPAP machine know when you stop breathing? ›
Automatic CPAP machines vary slightly in that they can detect a collapse of the airway by measuring resistance and react by increasing the pressure as needed during the night to further resolve the sleep apnea. These devices will also test lower pressures and adjust downward if possible.How many hours should you run on a CPAP machine? ›
CPAP is unquestionably the most successful treatment available for sleep apnea. Unfortunately average use of CPAP is only 4-5 hours/night, not the recommended 7 1/2 hours a night. This can lead to deadly consequences for many reasons. The 25% of patients who wear their CPAP all night every night are not at risk.What is Medicare doing about recalled CPAP machines? ›
If the equipment is more than 5 years old, Medicare will help pay for a replacement. Important: Register your recalled equipment with Philips so they know you need a replacement, and can provide information on the next steps for a permanent corrective solution.Is ResMed owned by Philips Respironics? ›
No. ResMed is a competitor to Philips that also makes CPAP, BiPAP, and other ventilator devices, and has no connection to the defective Philips CPAP and BiPAP machines that have been recalled.How do I replace my CPAP machine? ›
How do I get a new CPAP machine? Check with your insurance provider to see if you are eligible for a new CPAP machine. If you're eligible, your doctor can provide you with the prescription and other proper forms to take to your home medical equipment provider or ResMed Shop to get your new CPAP machine.
How do I join a Philips CPAP class action lawsuit? ›
If you've used a Philips sleep apnea machine and suffered cancer or damage to your lungs, liver, or kidneys as a result, you may be eligible for compensation from a Philips CPAP lawsuit. Call (800) 995-1212 or get a free case review today to learn more about your options.Is there a class action suit against Phillips? ›
The Philips recall covered an estimated 3.5 million sleep apnea devices. There is now a CPAP class action lawsuit with thousands of plaintiffs consolidated into a Multi-District-Litigation (MDL).Do I have to return my DreamStation? ›
Failure to return your original device to Philips could result in your being billed for payment of that device, as you now have two devices, but have only paid for one device. The enclosed DreamStation 2 Auto CPAP Advanced device is provided to you as a replacement for your existing CPAP device.Can sleep apnea go into remission? ›
Does sleep apnea go away? The answer is no, although it is a common question among people with a sleep apnea diagnosis. While there is no cure for this chronic condition, there are treatments and lifestyle changes that can reduce your sleep apnea symptoms.Why do people quit CPAP? ›
They quit for a variety of reasons, but mostly because the device can be cumbersome and uncomfortable. Sometimes, they quit because of confusing or stringent health insurance restrictions. But the health effects of untreated sleep apnea can be serious. People struggle with anxiety, tiredness and low productivity.Can I use my CPAP while awake? ›
People usually use a CPAP machine while they are sleeping. However, you may be wondering can you use CPAP therapy while awake? We're going to clear up the confusion that exists, so you can find out whether there is any benefit to using continuous positive airway pressure while awake. The short answer is yes, you can.Is ResMed part of a recall? ›
You may be wondering, “Are ResMed CPAP machines being recalled?” Rest assured, the CEO of ResMed has made a public announcement stating that ResMed CPAP machines are not impacted by the Philips recall.Why are people filing Philips CPAP lawsuits? ›
Why Are People Filing Philips CPAP Lawsuits? People are filing Philips CPAP lawsuits because the polyester-based polyurethane (PE-PUR) sound abatement foam in recalled Philips CPAP, BiPAP and ventilator devices may cause cancer and serious respiratory problems.Will Medicare pay for a new CPAP machine after 5 years? ›
Medicare will usually cover the cost of a new CPAP machine every five years. If you had a machine before enrolling in Medicare, Medicare may cover some of the costs for a replacement CPAP machine rental and accessories if you meet certain requirements.Do I own my CPAP machine? ›
After the rental period is over, you own the device. However, these insurance companies are often requiring proof that you are using the equipment and meeting their usage requirements (at least 4 hours per night for 70% of nights) in order to continue payment.
How many hours per night on average does Medicare require patients to wear CPAP? ›
Compliance is the measurement of how much you use your CPAP equipment and if it is working for you. According to Medicare, you must be using your machine 4 hours a day for 70% of the nights. Think of the first 90 days of treatment as a “trial period”.How do I get a refund from Philips? ›
You can place the return request by:
- Logging the request in the My Account section of your Philips Domestic Appliances E-Store Account.
- Calling the consumer care centre at 1800-108-1800 (Toll Free). ...
- Email us on firstname.lastname@example.org.
Risks from the foam include headache, asthma, allergic reactions and cancer-causing effects on internal organs, according to the Food and Drug Administration. The recalled devices include Dreamstation and SystemOne CPAP models and several other Philips machines, including Trilogy ventilators.Does CPAP reverse damage? ›
Although three months of CPAP therapy produced only limited improvements to damaged brain structures, 12 months of CPAP therapy led to an almost complete reversal of white matter abnormalities. Treatment also produced significant improvements in nearly all cognitive tests, mood, alertness and quality of life.What are the long-term side effects of using a CPAP machine? ›
- dry or runny nose.
- sore throat.
- dry mouth.
- dry eyes.
- nasal congestion.
- facial irritation.
- air leaks around the mask.
If you've used a Philips sleep apnea machine and suffered cancer or damage to your lungs, liver, or kidneys as a result, you may be eligible for compensation from a Philips CPAP lawsuit. Call (800) 995-1212 or get a free case review today to learn more about your options.How long does it take Medicare to pay off a CPAP machine? ›
Medicare pays the supplier to rent a CPAP machine for 13 months if you've been using it without interruption. After Medicare makes rental payments for 13 continuous months, you'll own the machine.