Phillips / Philips Respironics recent recall notice discussion thread

[Elle]

I wonder why it is just in the U.S.? Would other countries use different materials?

I'm due for a new machine this week and asked for the Dreamstation.

Looks like what we call a recall notice goes by another term internationally: From this Phillips page https://www.usa.philips.com/healthcare/ ... src-update

The recall notification (U.S. only) / field safety notice (International Markets) advises...

Hope your replacement goes smoothly!

Thanks for this. I called the supplier and the machine I ordered is the 2 but they are on back order so I might have to wait a bit which is ok. thanks for the help.

[Sea Papper]

So I've dug out some information about the foam that they use in the machine and its health risks.

You have no qualifications to evaluate any of the information you snipped off the internet.

From Philips: 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. (right after we get past releasing our financials and not fully disclosing this mess)

The results speak for themselves. Philips Respironics obviously failed to demonstrate the biocompatibility of the material used in the product as per ISO 10993-X. Why isn't the FDA filing criminal charges?

This is what they filed with the FDA. Who signed the ES-60601?
Biocompatibility Testing
The biocompatibility evaluation, for the DreamStation 2 System, was conducted in accordance with FDA Guidance, “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”,ISO 10993-1 “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process”, and ISO 18562-1 “Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 1: Evaluation and Testing within a Risk Management Process”, as recognized by FDA. The DreamStation 2 System has proven to be biocompatible when tested in its final, finished, form to both ISO 10993-1:2018 and ISO 18562-1:2017.

[JeffV]

Just to make sure I've got my models right - both the Dreamstation that I've been using for ~12-18 months, and my PR Auto 560 (which I kept around for backup) are affected by this, yes?

[nairotci]

Found this after I posted my own frustrated "letter". New to this chat stuff. I don't like it. I want my money back for my CPAP machine and I will go it alone. Pretty sure I had lung cancer about 6 months ago. Wonder if that is why? In any case, I have studied natural treatments for cancer for 5 years so treated myself for that, and the symptoms mostly went away. I stopped the treatment since my symptoms went away. I don't mind dying. I'm sort of looking forward to it. This is ridiculous! The money these companies make and they can't produce a safe product? Due to my dementia, I can't figure out complicated problems without help. This is complicated. Maybe I should get an attorney. Or just quit using a CPAP and take my chances. I don't sleep well no matter what anyway. It's much easier to just give up.

[Pugsy]

Just to make sure I've got my models right - both the Dreamstation that I've been using for ~12-18 months, and my PR Auto 560 (which I kept around for backup) are affected by this, yes?

Yep. I just got my email from cpap.com notifying me that a machine I purchased a while back was likely part of the recall and if you go to cpap.com ....all the System One listings have been pulled and the first generation DreamStation doesn't show a price.
The email pointed me to the official Phillips link posting the recall that I linked to in my first post.
The machine I purchased several years ago was the PR System One Auto model 560.
I think this pretty much confirms my suspicions about what the "Q" series means.

The only Respironics machine that the bulk of us use (cpap/apap/bipap) that isn't affected is the DreamStation 2 model just released.
Good luck finding someone with those in stock to buy. I didn't check if cpap.com had any but if they do they won't last long.

Now the higher end specialty machines that are in the real ventilator class...a lot of them have escaped the recall so people using those special high end models need to check closely to see if their machines are included or not in the recall.

For most of us with just plain OSA....any model newer than the M series up to the DreamStation 2 are going to be included in the recall.

I don't have that machine personally now...it was bought to be shipped out of the US..and that person no longer has it since they long ago decided ResMed suited them better.

[JLROhio]

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Did someone say, "Class Action Lawsuit"

Looks like the Sharks are out looking for "Victims" of Phillips machines - https://www.bgandg.com/cpap

Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique.

Does anyone know what model CPAP that is in their online ad?

[JLROhio]

...
It's not like next week they will have this whole situation fixed...try next year. Over 400 million units...it's going to be a long slow process.

Question for you...
I think I've seen a couple of times you use the term 400 million units affected.

According to this article on Reuters, https://www.reuters.com/business/health ... 021-06-14/, ", Philips Chief Executive Frans van Houten said the company was one of the largest makers of sleep apnea machines and ventilators. Between 3 million and 4 million would be targeted in the recall, he said."

Did you read somewhere else 400 million?? That seems a little high of a number.

[Pugsy]

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Does anyone know what model CPAP that is in their online ad?

Looks like an old F & P machine of some sort to me. No time to go look around to see but the newest models have the same body style but now in black I think.

Respironics has never had one that looks like that ...I don't think.

I think they stole a stock photo off the web from some place.
Probably from a mask ad more than machine ad.

[amenite]

I had been looking for an excuse to try a Resmed machine for a few years now and it looks like this is my big chance. I suppose after some months I'll get satisfaction on my two PRS 560 machines, but for now I've got a new Air Sense Auto Set 10 on the way.

Only question I have now is how do I handle it in Oscar - separate profiles for the different manufacturers/product lines? Or do they combine nicely under one profile? It should be interesting in any case.

[JLROhio]

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Does anyone know what model CPAP that is in their online ad?

Looks like an old F & P machine of some sort to me. No time to go look around to see but the newest models have the same body style but now in black I think.

Respironics has never had one that looks like that ...I don't think.

I think they stole a stock photo off the web from some place.
Probably from a mask ad more than machine ad.

Haha... I wonder if the lawyers from Fisher & Paykel Healthcare will reach out to these lawyers and make them take it down or risk a defamation lawsuit...

Ah, the games lawyers play!

[tisket]

I think this pretty much confirms my suspicions about what the "Q" series means.

Glad I wasn't the only one confused by what "Q series" meant.

For most of us with just plain OSA....any model newer than the M series up to the DreamStation 2 are going to be included in the recall.

Unfortunately I don't know the historical lineup of the PR product line (is there a list somewhere?) so..do you know if the PR System One REMStar 60 Series Auto with Bluetooth would be included? I don't know if that was older or newer than the M series. Thanks.

[Pugsy]

Unfortunately I don't know the historical lineup of the PR product line (is there a list somewhere?) so..do you know if the PR System One REMStar 60 Series Auto with Bluetooth would be included? I don't know if that was older or newer than the M series. Thanks.

I for sure know the line up since 2009 and a bit before that even.

Any System One machine is going to be NEWER than any M Series machine.

First System One machine was released in the late fall of 2009 and it replaced the M series model line.

This recall pretty much encompasses all the System One...50 and 60 series.

[zonker]

I had been looking for an excuse to try a Resmed machine for a few years now and it looks like this is my big chance. I suppose after some months I'll get satisfaction on my two PRS 560 machines, but for now I've got a new Air Sense Auto Set 10 on the way.

Only question I have now is how do I handle it in Oscar - separate profiles for the different manufacturers/product lines? Or do they combine nicely under one profile? It should be interesting in any case.

you could do separate profiles.

i was fortunate enough to have a second sd card laying around when i went from resmed to philips(and now back to resmed), so i just used separate cards and didn't worry about it.

if i hadn't had that card, i'm so cheap that i would've done the two profile thing.

[Pugsy]

I had been looking for an excuse to try a Resmed machine for a few years now and it looks like this is my big chance. I suppose after some months I'll get satisfaction on my two PRS 560 machines, but for now I've got a new Air Sense Auto Set 10 on the way.

Only question I have now is how do I handle it in Oscar - separate profiles for the different manufacturers/product lines? Or do they combine nicely under one profile? It should be interesting in any case.

OSCAR doesn't care. I have I think at least 6 different machines under one profile.
OSCAR will combine the data for you.
You can keep it separate if you wish but it's not needed.
The new machine will show up as a "change in settings" on the main statistics page down at the bottom.

[tisket]

Thanks Pugsy.