September 01, 2021
September 01, 2021

Philips Respironics Recall

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 medical devices 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 cleaning methods 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 class i 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
  • REMStar SE 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 the Philips 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:

The size

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.

Shipping Problem

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.

Final Thoughts

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.

Written by Karina Lima

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