Philips respironics recall

[Nucky]

Please if you use a CPAP or Bipap machine check out this story and Google for other stories. Compiling information on your own and making your own decision seems to be the path after a full day of bouncing around on the phone between Apria, My Pulmonary Doctor, and United Health Care.

It is a very serious situation. Best of luck with your decision on continuing respiratory therapy or trying to go without it because of the chance of a carcinogen being released into your lungs.

I did my best here. I'm not a Doctor.

Medical Device recall notification (U.S. only) / field safety notice (International Markets)
Philips Respironics

There is nothing we take more seriously than providing patients with high-quality products that are safe and reliable. If an issue arises, we are proactive in communicating and addressing it as we work tirelessly towards a resolution.

On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.



At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.



The company also indicated that analysis of potential health risks was ongoing and that further information would be provided when available. As a result of extensive ongoing review following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (International Markets) for specific affected devices.



The recall notification (U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. Additionally, the notification provides details of our robust and comprehensive repair and replacement program, to correct this issue as efficiently and thoroughly as possible.


The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions:


For patients using life-sustaining mechanical ventilator devices:



Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation.

For patients using BiLevel PAP and CPAP devices:


Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment.

We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.



This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain, and other functions to support the correction.



We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.

What you need to do

What devices are affected

Questions and answers


Help
Questions? Call
877-907-7508

Toll-free in the USA
Outside the USA call
(0044) 20 8089 3822

Begin registration process

Recall notification (U.S. only) / field safety notice (International Markets) (137.0KB)

What you need to do


Philips is committed to rectifying this issue through a robust and comprehensive repair and replacement program. We have established a claims processing and support center to assist you.

Icon Business

Durable Medical Equipment Providers, Distributors, or Medical Institutions​


Click the link below to begin our registration process. If you are in the United States, you will receive a letter by June 23, 2021, from Philips about this issue that contains log-in credentials for the registration website. If you are located outside of the United States, you will receive the letter shortly thereafter. If you do not receive this letter, please call the number below.



After registration, we will notify you with additional information as it becomes available.

Begin registration process

877-907-7508


Downloadable resources
Template web copy block for DME and HCP use (26.0KB)
FAQs (193.0KB)
Physician engagement letter for DME and HCP use (82.0KB)
Icon Patient

Patients, Users, or Caregivers​


Philips has established a registration process that allows Patients, Users, or Caregivers​ to look up their device serial number and begin a claim if their unit is affected.



At this time, this process is only available for Patients, Users, or Caregivers in the USA and Canada. More countries will be added shortly.

Begin registration process

877-907-7508

Icon Medical professional

Physicians and other medical care providers​


Click the link below for additional clinical details on the issue and other information to help you advise your patients who have been impacted.

Learn more

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What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)?


The recall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products.



Additionally, the device Instructions for Use provide product identification information to assist with this activity.



Products affected by this recall notification (U.S. only) / field safety notice (International Markets) include:


CPAP and BiLevel PAP Devices
All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator, Minimum Ventilatory Support, Facility Use
E30

E30
(Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting
DreamStation ASV

DreamStation
ASV
DreamStation AVAPS

DreamStation
ST, AVAPS
60 Series CPAP, ASV

SystemOne
ASV4
C Series AVAPS/ST

C Series
ASV, S/T, AVAPS
OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus
In-Lab Titration Device

Non-continuous Ventilator
60 Series CPAP, ASV

SystemOne
(Q series)
DreamStation CPAP

DreamStation
CPAP, Auto CPAP, BiPAP
DreamStation Go

DreamStation GO
CPAP, APAP
Dorma 400, 500

Dorma 400, 500
CPAP
REMStar SE Auto CPAP

REMStar SE Auto
CPAP

Mechanical Ventilators
All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator
Trilogy 100

Trilogy 100
Ventilator
Trilogy 200

Trilogy 200
Ventilator
Trilogy 200

Garbin Plus, Aeris, LifeVent
Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A 40/30

A-Series BiPAP Hybrid A30
(not marketed in US)
V30

A-Series BiPAP V30 Auto
Ventilator

Continuous Ventilator, Non-life Supporting
A 40/30

A-Series BiPAP A40
(not marketed in US)
A 40/30

A-Series BiPAP A30
(not marketed in US)

What products are not affected and why?


Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.



Products not affected by this recall notification (U.S. only) / field safety notice (International Markets) include:


Trilogy Evo

Trilogy Evo OBM

Trilogy EV300

Trilogy 202

BiPAP A40 EFL

BiPAP A40 Pro

M-Series

DreamStation 2

Omnilab (original based on Harmony 2)

Dorma 100, Dorma 200, & REMStar SE

All oxygen concentrators, respiratory drug delivery products, airway clearance products.
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Questions and answers
Are affected devices safe for use? Should affected devices be removed from service?

The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions:



For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.


Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.



Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due to this issue?
When will the correction for this issue begin? How long will it take to address all affected devices?
Are affected devices continuing to be manufactured and/or shipped?
Is this a recall? Have regulatory authorities classified the severity of the recall?
How will Philips address this issue? Are affected devices being replaced and/or repaired? Are customers entitled to a warranty replacement, repair, service, or other mitigations?
Are there any steps that customers, patients, users, and/or clinicians should take regarding this issue?
What is the cause of this issue? Was it a design, manufacture, supplier, or other problem?
How did this happen, and what is Philips doing to ensure it will not happen again?
What is meant by "high heat and humidity" being one of the causes of this issue?
Do affected units exhibit features that customers/users should watch out for? Particles or other visible issues?
Can Philips replace products under warranty or repair devices under warranty?
In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Will existing patient devices that fail be replaced?
Is Philips certain that this issue is limited to the listed devices? Is there any possibility others are affected?

:pray: God Help Us!

[villagetinker]

WOW you found a lot more info than I did, great work, now to check out which one we have.

[Kahuna32162]

Nucky, Thanks for the info you provided. After a few calls, I've found that the problem seems to stem from users that have an ozone type cleaning system ie. so-clean or the like. They apparently degrade the polyester foam inside the Dreamstation machine and cause the patient to inhale the degraded material. Luckily, I do not have one of those cleaning systems, as I've felt they were really not necessary and more a hyped rip off. I do however have friends that use them and I'm getting word to them now. Thanks again for the head's up.

[GrumpyOldMan]

First, if you have sleep apnea it is very important to NOT stop therapy without discussing it with your doctor. Sleep Apnea is associated with MANY elderly issues including dementia and Alzheimers.

Second, I use Resmed and my wife uses Respironics, and they are supplied and maintained through the VA, so we will. contact the VA at once.

We do not use any cleaning equipment but clean by hand instead.

Thank you very much for posting this extensive information, I appreciate it.

And a word of advice, if you snore, if you wake up tired, if you are tired during the day, ask your PCP to refer you for a sleep study. It is fast, easy, painless (you sleep) and if you do have sleep apnea a CPAC machine can significantly imp[rove your quality of life, and help reduce the odds of dementia and other conditions.

[Nucky]

I'm on my third day of trying to resolve this problem thru my Doctor, United Health Care, Philip Respironics, and Apria.

I would rate my Doctor as the most concerned but the only information he has is what I posted. They were not aware of the problem until I let them know about it. United Health Care has stood on its head to try and help me. The wall that we are all hitting is Phillips and Apria.

I am willing to purchase a new unit and worry about the money later or there may be no later.

This sucks. We were just getting ready to head north to see the family. On hold again until I can work this out. I'm done for today. Been on the phone since 8 am.

My respect for United Health Care is Very High. My Doctor and his staff are willing to help in any way they can. They hit the same roadblocks like everyone else.

I hate to do it but it may be time to lawyer up. God, I never wanted to do that again. I wanted to be done with lawyers. I think I'll think about it until Monday. Hope I'm still around.

[alanmcdonald]

You can register your CPAP with Philips and get into the line for when they start repair/replacement process.

I did that and then called Philips and they told me they do not know yet how the process will work.

[villagetinker]

I was able to "register" and was told the unit we have is not part of the recall.

[Nucky]

I'm happy for you villagetinker. It is really a terrible experience to go thru without the machine being fully operational. I'm up all night and wake up with that old familiar wiped-out feeling.

The biggest problem is, no answers from anybody. Removing the foam from the machine looks like a walk in the park. Maybe that's the next move. I Gotta try something.

[villagetinker]

I'm happy for you villagetinker. It is really a terrible experience to go thru without the machine being fully operational. I'm up all night and wake up with that old familiar wiped-out feeling.

The biggest problem is, no answers from anybody. Removing the foam from the machine looks like a walk in the park. Maybe that's the next move. I Gotta try something.

You might try another or some replacement foam, my understanding the foam breaking down takes some time so replacing my buy you some time until they get around to replacing or repairing these units.

[Kahuna32162]

Nucky, I've got a spare you can borrow if that would help get you thru the recall or repairs. PM me if needed. Thx

[Nucky]

Nucky, I've got a spare you can borrow if that would help get you thru the recall or repairs. PM me if needed. Thx

Thanks Kahuna. Very Neighborly of you.

A gentleman at United Health Care told me today that he has something good coming my way tomorrow. ?????? We'll see. :pray:

[GrumpyOldMan]

I got this from the VA today. I have a Resmed, but my wife uses the Phillips.

"North Florida/South Georgia Veterans Health System continues to take action in response to the Philips Respironics voluntary recall announcement. As previously mentioned, this recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Veterans with severe breathing difficulties, significant pulmonary, cardiovascular or neurologic comorbidities, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators) should not discontinue the use of their machine and await a call from the respiratory team for further guidance. "

[Nucky]

Well, I did a Foamectomy the day after my last post on my Phillips Respironics Boat Anchor. It was a piece of cake overall. You just have to take your time and get the residual foam that is stuck to the housing that holds the motor and put it back together carefully.

In no way. shape or form do I advise anyone to do this procedure. I was to the point where I had to try something. Don't do this because I did cause I'm no YouTube Doctor. The foam did not come out in one piece like the videos on YouTube. My foam was moist and crumbled into pieces. Not good. I have an appointment with Florida Cancer Specialists. We'll see whats cooking. I'd rathe know and face it if it's bad news.

The machine was not one bit noisier than it was with the foam in it.

Suprise of surprises I got a call from Breath Easy in Leesburg and they offered me a RESMED 10s or S10. I haven't moved that quick in a while. $1185 out the door. Too much but who cares. I'm set for now and grateful.

Fantastic:
1) Dr. Diaz and staff in Leesburg.
2) United Health Care. They didn't give me the answer I wanted but their effort on my behalf was phenomenal.
3) Breathe Easy - Leesburg :clap2::clap2::clap2: Gail 352-483-0911

The Dirty No Good Scoundrels:
1) Apria
2) Phillips Respironics - Dirty Mutts. They have hurt a lot of people,
millions in fact. Shame Shame Shame. :boxing2:

[Mistymom]

I received my replacement Dream Station 2 a few days ago!!!! It appeared out of the blue with no advance warning.
It seems like a good replacement for my Dream Station, however I'm having quite a few problems.

First, from what Aerocare tells me, it should have arrived with all of my previous settings...not true. It came with a pressure of 4 (I'm a 10). Also, I don't have "privileges" on some of the custom settings. I called Aerocare in Ocala and they don't have the slightest idea how to fix it 🤔 and told me to call Phillips. Philips couldn't believe that Aerocare told me this, since they are the biggest supplier of CPAP's and supplies in the US. They told me to call Aerocare back and tell them to call Philips to "get educated". I am in them middle of this mess, with Aerocare mad at me for having a machine that doesn't work and they want me to go to Ocala to "hopefully" learn how to fix it.

Does anyone have a REALLY GOOD CPAP supplier that I can switch to for all of my services, now and in the future?

[Ben Franklin]

Whao! Thanks for the heads up. If it wasn't pouring outside, I may never have know about this. Guess I'll have to wait until Monday.

Thanks, again.

[chuckandbernice]

My BiPAP replacement arrived last week. I was a brand new unit and all the packaging for sending the old one back was included. All I had to do was insert the chip, connect the humidifier section, and insert the communication module. All the original settings were in place.