What Federal Law did they break and how did they break it? Please be specific.
Phillips / Philips Respironics recent recall notice discussion thread
- Dog Slobber
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Re: Sticky: Phillips Respironics recent recall notice discussion thread
_________________
Machine: AirCurve™ 10 VAuto BiLevel Machine with HumidAir™ Heated Humidifier |
Mask: AirFit™ P30i Nasal Pillow CPAP Mask with Headgear Starter Pack |
Additional Comments: Min EPAP: 8.2, Max IPAP: 25, PS:4 |
Re: Sticky: Phillips Respironics recent recall notice discussion thread
Dog Slobber wrote: ↑Wed Jun 16, 2021 11:31 amWhat Federal Law did they break and how did they break it? Please be specific.

_________________
Machine: AirCurve™ 10 VAuto BiLevel Machine with HumidAir™ Heated Humidifier |
Mask: AirFit™ P10 Nasal Pillow CPAP Mask with Headgear |
people say i'm self absorbed.
but that's enough about them.
Oscar-Win
https://www.apneaboard.com/OSCAR/OSCAR-1.5.1-Win64.exe
Oscar-Mac
https://www.apneaboard.com/OSCAR/OSCAR-1.5.1.dmg
but that's enough about them.
Oscar-Win
https://www.apneaboard.com/OSCAR/OSCAR-1.5.1-Win64.exe
Oscar-Mac
https://www.apneaboard.com/OSCAR/OSCAR-1.5.1.dmg
Re: Sticky: Phillips Respironics recent recall notice discussion thread
i'll trade ya!ChicagoGranny wrote: ↑Wed Jun 16, 2021 10:59 amIf I had a Philips machine, I would keep merrily using it until they decided to replace it. This panic is for chemophobes and lawyers.
_________________
Machine: AirCurve™ 10 VAuto BiLevel Machine with HumidAir™ Heated Humidifier |
Mask: AirFit™ P10 Nasal Pillow CPAP Mask with Headgear |
people say i'm self absorbed.
but that's enough about them.
Oscar-Win
https://www.apneaboard.com/OSCAR/OSCAR-1.5.1-Win64.exe
Oscar-Mac
https://www.apneaboard.com/OSCAR/OSCAR-1.5.1.dmg
but that's enough about them.
Oscar-Win
https://www.apneaboard.com/OSCAR/OSCAR-1.5.1-Win64.exe
Oscar-Mac
https://www.apneaboard.com/OSCAR/OSCAR-1.5.1.dmg
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Re: Sticky: Phillips Respironics recent recall notice discussion thread
ARE YOU OK? come on, this machine can cause cancer!ChicagoGranny wrote: ↑Wed Jun 16, 2021 10:59 amIf I had a Philips machine, I would keep merrily using it until they decided to replace it. This panic is for chemophobes and lawyers.
Re: Sticky: Phillips Respironics recent recall notice discussion thread
So can the sun, yet I bet you still go outside.supermikelala wrote: ↑Wed Jun 16, 2021 12:03 pmARE YOU OK? come on, this machine can cause cancer!ChicagoGranny wrote: ↑Wed Jun 16, 2021 10:59 amIf I had a Philips machine, I would keep merrily using it until they decided to replace it. This panic is for chemophobes and lawyers.
My machines are only 3 months old so I think it'll be a while before the foam will degrade. So I'll keep using it.
Re: Sticky: Phillips Respironics recent recall notice discussion thread
I'm with CGranny.
I would put a filter on the outlet hose (to stop the particles) and keep on keeping on.
I am not stopping my therapy for a what if, when I know the consequences not treating Apnea.
JPB
I would put a filter on the outlet hose (to stop the particles) and keep on keeping on.
I am not stopping my therapy for a what if, when I know the consequences not treating Apnea.
JPB
_________________
Machine: ResMed AirSense™ 10 AutoSet™ CPAP Machine with HumidAir™ Heated Humidifier |
Mask: AirFit™ P10 Nasal Pillow CPAP Mask with Headgear |
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Last edited by jimbud on Wed Jun 16, 2021 1:02 pm, edited 1 time in total.
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Re: Sticky: Phillips Respironics recent recall notice discussion thread
I spoke with my Dr's office today. They told me they advise stopping using the DreamStation. They are sending a prescription to the DME for a DreamStation 2.
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- Sea Papper
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Re: Sticky: Phillips Respironics recent recall notice discussion thread
Technically speaking, any medical device recall is due to the manufacturer violating federal law. Be it whether the design was faulty, the testing was faulty, or the manufacturing was faulty.Dog Slobber wrote: ↑Wed Jun 16, 2021 11:31 amWhat Federal Law did they break and how did they break it? Please be specific.
For starters:
Title 21 of the Code of Federal Regulations
- Sec. 868.5273 Positive airway pressure delivery system.
- (1) The patient-contacting components of the device must be demonstrated to be biocompatible.

Demonstrate means demonstrate using FDA acceptable test standards and methods. If you actually do that correctly the product won't end up recalled. Philips obviously broke Federal Law.

I'll reserve judgement on the public statements they made to shareholders on April 26, 2021 concerning the possible 250M EUR expense. The class action attorneys will be all over that-en-nat.

- Dog Slobber
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Re: Sticky: Phillips Respironics recent recall notice discussion thread
Technically speaking, you're full of shit.Sea Papper wrote: ↑Wed Jun 16, 2021 1:02 pmTechnically speaking, any medical device recall is due to the manufacturer violating federal law. Be it whether the design was faulty, the testing was faulty, or the manufacturing was faulty.Dog Slobber wrote: ↑Wed Jun 16, 2021 11:31 amWhat Federal Law did they break and how did they break it? Please be specific.
For starters:
Title 21 of the Code of Federal Regulations
- Sec. 868.5273 Positive airway pressure delivery system.
- (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
![]()
Demonstrate means demonstrate using FDA acceptable test standards and methods. If you actually do that correctly the product won't end up recalled. Philips obviously broke Federal Law.![]()
I'll reserve judgement on the public statements they made to shareholders on April 26, 2021 concerning the possible 250M EUR expense. The class action attorneys will be all over that-en-nat.![]()
Just because a device has been recalled, does not mean it didn't meet the required standards. Testing is not and cannot be exhaustive.
_________________
Machine: AirCurve™ 10 VAuto BiLevel Machine with HumidAir™ Heated Humidifier |
Mask: AirFit™ P30i Nasal Pillow CPAP Mask with Headgear Starter Pack |
Additional Comments: Min EPAP: 8.2, Max IPAP: 25, PS:4 |
Last edited by Dog Slobber on Wed Jun 16, 2021 1:35 pm, edited 1 time in total.
Re: Sticky: Phillips Respironics recent recall notice discussion thread
_________________
Machine: ResMed AirSense™ 10 AutoSet™ CPAP Machine with HumidAir™ Heated Humidifier |
Mask: AirFit™ P10 Nasal Pillow CPAP Mask with Headgear |
Additional Comments: Sleep on a Buckwheat Hull Pillow. |
- Sea Papper
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Re: Sticky: Phillips Respironics recent recall notice discussion thread
OK miss potty-mouth. Using a toxic material in the air pathway is not even a testing thing. Its just common sense and a kindergarten analysis would have flagged the problem. The devices ARE being recalled because they have FAILED to meet the required standards.Dog Slobber wrote: ↑Wed Jun 16, 2021 1:21 pmTechnically speaking, you're full of shit.Sea Papper wrote: ↑Wed Jun 16, 2021 1:02 pmTechnically speaking, any medical device recall is due to the manufacturer violating federal law. Be it whether the design was faulty, the testing was faulty, or the manufacturing was faulty.Dog Slobber wrote: ↑Wed Jun 16, 2021 11:31 amWhat Federal Law did they break and how did they break it? Please be specific.
For starters:
Title 21 of the Code of Federal Regulations
- Sec. 868.5273 Positive airway pressure delivery system.
- (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
![]()
Demonstrate means demonstrate using FDA acceptable test standards and methods. If you actually do that correctly the product won't end up recalled. Philips obviously broke Federal Law.![]()
I'll reserve judgement on the public statements they made to shareholders on April 26, 2021 concerning the possible 250M EUR expense. The class action attorneys will be all over that-en-nat.![]()
Just because a device has been recalled, does not mean it didn't meet the required standards. Testing is not and cannot be exhaustive.
The patient-contacting components of the device must be demonstrated to be biocompatible. - is that really that difficult? Oh look a cheap toxic material...lets stick it in the air path. *golf clap* This is what happens when dumb a$$ project managers and boot licking middle managers are tasked with making technical decisions. Oh look that foam only cost $0.002, let's use that.
Go shill for some other company selling snake oil, and learn yourself some manners. Philips obviously broke Federal Law.

Re: Sticky: Phillips Respironics recent recall notice discussion thread
Play nice boys....no more of the pissing contest infighting and derailing of this thread with the pissing contests.
Please...thank you in advance for not derailing the thread anymore with name calling and personal attacks.
Take it private if you wish to continue the personal attacks.
Please...thank you in advance for not derailing the thread anymore with name calling and personal attacks.
Take it private if you wish to continue the personal attacks.
_________________
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Re: Sticky: Phillips Respironics recent recall notice discussion thread
I don't think it was a problem between the 'boys', but between the boy and a man without cognitive dissonance, just trying to deflect the 4 letter attack and the lack of reasoning.
Not fair to call them BOTH out. IMHO.
I am still trying to figure out in what world "Just because a device has been recalled, does not mean it didn't meet the required standards." is a reasonable thing to say.
As much as I am concerned about the current Philips issue, I am MUCH more concerned that they would NOT have thoroughly tested their device and all its parts before foisting them on all of us.
If I can no longer trust someone who has failed at their primary task, I will certainly not buy from them again. They have revealed their true nature, and I would be a fool not to listen.
Not fair to call them BOTH out. IMHO.
I am still trying to figure out in what world "Just because a device has been recalled, does not mean it didn't meet the required standards." is a reasonable thing to say.
As much as I am concerned about the current Philips issue, I am MUCH more concerned that they would NOT have thoroughly tested their device and all its parts before foisting them on all of us.
If I can no longer trust someone who has failed at their primary task, I will certainly not buy from them again. They have revealed their true nature, and I would be a fool not to listen.
Re: Sticky: Phillips Respironics recent recall notice discussion thread
I have had an intermittent dry cough I attributed to Gerd and some shortness of breath I attributed to weight gain which caused me to get covid tested. I even went to an ent for having to clear my throat often.
I suspected it was the cpap machine because I wasnt cleaning it often.
The VA said keep using it unless you used ozone or other system to clean it.
I may just buy a ds2 out of pocket.
I suspected it was the cpap machine because I wasnt cleaning it often.
The VA said keep using it unless you used ozone or other system to clean it.
I may just buy a ds2 out of pocket.
_________________
Machine: DreamStation Auto CPAP Machine |
Mask: Fisher & Paykel Vitera Full Face Mask with Headgear (S, M, or L Cushion) |
Additional Comments: ahi 21 in sleep lab ahi 7-10 now system indicates large leak |
Re: Sticky: Phillips Respironics recent recall notice discussion thread
Pugsy - the issue is them coming to this thread and trolling their tired worn out mouths over a topic they obviously disagree with, but, rather than just leave it alone and just not visit the post, they jump on here flashing their junk like two-bit street walkers demanding that their 1-2% opinion matters more than the lot of us that are far more concerned, and most don't even have Philips CPAPs. You're just coming in here to stick your finger in the nest as opposed to going away. We've gotten plenty of your run of the mill BS where you want to set the bar so low for Philips it may as well be in hell (probably where they belong, when this all settles out). But you're not changing anybody's mind by coming on here. People just flat out disagree with your opinion. Go start another thread in OppositeVille and bitch among yourselves there. But, oh no, you'll be back...like antagonistic moths to a damn flame. Can't help yourselves. Only you'll spin the message and run your mouths about how your entitled and we're alarmist, and people need to hear your opinion and your thoughts matter, we are wrong and you are right, diatribe, diatribe...you can't have your pudding unless you eat your meat, and we're here with our 2% MEAT to jamb it down your throats because you need to have it and hear it. So here's a preemptive Don't CARE, Don't give Two-Fricking Red Cents what you think. You can pound sand in one ear and out the other til the cows come home, just go do it somewhere else.