Philips Respironics Recall V2.0 Questions and Answers
- Dog Slobber
- Posts: 3954
- Joined: Thu Feb 15, 2018 2:05 pm
- Location: Ontario, Canada
Re: Philips Respironics Recall V2.0 Questions and Answers
_________________
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: Philips Respironics Recall V2.0 Questions and Answers
When did they open the recall to APAP machines? When the recall was announced I checked the site with both my System One 50 series APAP machines and it said they were not in the recall. Just checked the site today and it looks like the recall website has been updated to include APAPs now.
Both my machines fall into the recall so it's into the recall queue I go.
Regards,
Chris
Both my machines fall into the recall so it's into the recall queue I go.
Regards,
Chris
Hosehead since 2011-11-30
Machine: ResMed AirSense 11Autoset
Mask: ResMed AirFit N20 Nasal Mask
Software: ResMed myAir and OSCAR -Open Source CPAP Analysis Reporter
Machine: ResMed AirSense 11Autoset
Mask: ResMed AirFit N20 Nasal Mask
Software: ResMed myAir and OSCAR -Open Source CPAP Analysis Reporter
Re: Philips Respironics Recall V2.0 Questions and Answers
Your machines were in the recall from day one, you just mis-typed the numbers, it was a common problem early on, and bad design of their web page, giving lots of people false negatives.
Get OSCAR
Accounts to put on the foe list: dataq1, clownbell, gearchange, lynninnj, mper!?, DreamDiver, Geer1, almostadoctor, sleepgeek, ajack, stom, mogy, D.H., They often post misleading, timewasting stuff.
Accounts to put on the foe list: dataq1, clownbell, gearchange, lynninnj, mper!?, DreamDiver, Geer1, almostadoctor, sleepgeek, ajack, stom, mogy, D.H., They often post misleading, timewasting stuff.
Re: Philips Respironics Recall V2.0 Questions and Answers
LOL, I can believe that.
Thanks.
Chris
Hosehead since 2011-11-30
Machine: ResMed AirSense 11Autoset
Mask: ResMed AirFit N20 Nasal Mask
Software: ResMed myAir and OSCAR -Open Source CPAP Analysis Reporter
Machine: ResMed AirSense 11Autoset
Mask: ResMed AirFit N20 Nasal Mask
Software: ResMed myAir and OSCAR -Open Source CPAP Analysis Reporter
- ChicagoGranny
- Posts: 14409
- Joined: Sun Jan 29, 2012 1:43 pm
- Location: USA
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- Posts: 2
- Joined: Wed Nov 10, 2021 12:37 pm
Re: Philips Respironics Recall V2.0 Questions and Answers
I've read a lot of the postings here, Medicare notified me of the recall. Phillips nor Lincare didn't. They still call trying to replace the supplies.Twice they have called, and I tell them my machine is recalled. Tried to get Lincare to get me a new machine but that is a no go until my Dreamstation 1 is five years old (december 16th, 2021) I looked in to buying a new machine from a different company. That would have been $2100.00 out of pocket they didn't tell my doctor what type. but was $1800.00 out of pocket and $300.00 for supplies. Lincare wouldn't sell a machine to me. I can start the process anew thru Medicare after 16th of december. Until then I"ll tough it out. Medicare gave me the information online. I got a new prescription, I looked online for prices on a new machine, I could be waiting a month anyway do to being out of stock, and Covid19 mailing they all say. Can't win for not trying.
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- Posts: 2
- Joined: Wed Nov 10, 2021 12:37 pm
Re: Philips Respironics Recall V2.0 Questions and Answers
I forgot, I also used the SoClean 1 to clean my machine, I have never seen any foam particles in my hose or water chamber. From what I have seen posted SoClean is suing Phillips. Phillips recommends not using Ozone cleaning. Lincare never told me that and they new I Had a SoClean.
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- Posts: 508
- Joined: Sat Feb 13, 2021 2:40 am
Re: Philips Respironics Recall V2.0 Questions and Answers
The following article was in my news feed.
TLTR: Silicone foam used for replacement program now suspect. FDA requests more testing. Phillips Respironics has known about the foam problems since at least 2008.
TLTR: Silicone foam used for replacement program now suspect. FDA requests more testing. Phillips Respironics has known about the foam problems since at least 2008.
https://www.fda.gov/news-events/press-a ... e-machines
https://www.fda.gov/media/154099/download
Following the initial recall, Philips Respironics developed a plan to repair the polyester-based polyurethane foam in the recalled CPAP and BiPAP devices with a different, silicone-based foam. The FDA initially approved this plan based, in part, on testing the company provided to the FDA in June on the new foam.
However, during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the agency, regarding the silicone-based foam used in a singular, similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Similar testing provided by Philips Respironics to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.
The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.
ResMed Lumis Tx - VAuto mode
Re: Philips Respironics Recall V2.0 Questions and Answers
This just gets better and better. Has anyone attempted to contact their government reps and/or state AGs?GrumpyHere wrote: ↑Sat Nov 13, 2021 6:45 pmTLTR: Silicone foam used for replacement program now suspect. FDA requests more testing.
_________________
Machine: PR System One REMStar 60 Series Auto CPAP Machine |
Mask: DreamWear Nasal CPAP Mask with Headgear |
Humidifier: 60 Series Heated Humidifier for Non-Heated Tubing |
Additional Comments: Phillips SystemOne w/ Humidifier for daily use. (Not listed above) Airmini for travel. |
Daily Driver (normally sans recall): Phillips SystemOne w/ Humidifier / DreamWear Nasal Cushion
Travel Unit (now currently daily driver during recall): ResMed Airmini / AirFit P10
Travel Unit (now currently daily driver during recall): ResMed Airmini / AirFit P10
- ChicagoGranny
- Posts: 14409
- Joined: Sun Jan 29, 2012 1:43 pm
- Location: USA
Re: Philips Respironics Recall V2.0 Questions and Answers
Gosh, If the FDA has suspicions about silicone foam in Philips products, perhaps they should also take a look at Resmed!!! How does one identify which Resmed CPAP's have the silicone 'death' foam????GrumpyHere wrote: ↑Sat Nov 13, 2021 6:45 pmThe following article was in my news feed.
TLTR: Silicone foam used for replacement program now suspect. FDA requests more testing. Phillips Respironics has known about the foam problems since at least 2008.
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Machine: DreamStation 2 Auto CPAP Advanced with Humidifier |
Mask: Fisher & Paykel Vitera Full Face Mask with Headgear (S, M, or L Cushion) |
Additional Comments: Resmed AirSense 10 Auto with Humidifier |
- ChicagoGranny
- Posts: 14409
- Joined: Sun Jan 29, 2012 1:43 pm
- Location: USA
- Grouchy Bear
- Posts: 27
- Joined: Wed Jan 20, 2021 6:48 am
- Location: Deep in a gold mine somewhere in Alaska
Re: Philips Respironics Recall V2.0 Questions and Answers
This seems to be 'pretty much everything' in the category of PR machines:
https://www.youtube.com/watch?v=plC1aUPbcdw
https://www.youtube.com/watch?v=plC1aUPbcdw
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Machine: ResMed AirSense™ 10 AutoSet™ CPAP Machine with HumidAir™ Heated Humidifier |
Mask: Fisher & Paykel Vitera Full Face Mask with Headgear (S, M, or L Cushion) |
I'm RETIRED Quit asking me to do stuff
ResMed AirSense 10 Autoset - F&P Vitera
ResMed AirSense 10 Autoset - F&P Vitera
Re: Philips Respironics Recall V2.0 Questions and Answers
I'm not sure how much truth there is to LankyLeft and CPAPReviews about possibly of the recall of the DreamStation 2, but it's concerning. The theory from LankyLeft, that the device sold outside of the USA that gave off VOCs was the DreamStation 2. However there's no confirmation of this per the FDA's letter to Phillips. It's an absolutely crazy situation for those with Philips Dreamstation 1s and Dreamstation 2s.
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Machine: DreamStation Auto CPAP Machine with Heated Humidifier |
Mask: ResMed AirFit F30i Full Face CPAP Mask with Headgear |
Humidifier: DreamStation Heated Humidifier |
Phillips Dreamstation 2 Auto CPAP with Humidifier **
Re: Philips Respironics Recall V2.0 Questions and Answers
Not a damn thing. But it would make me feel better to have some investigation of the ineptitude.ChicagoGranny wrote: ↑Sun Nov 14, 2021 2:08 pmWTH would you expect them to do that would be of benefit to anyone?
_________________
Machine: PR System One REMStar 60 Series Auto CPAP Machine |
Mask: DreamWear Nasal CPAP Mask with Headgear |
Humidifier: 60 Series Heated Humidifier for Non-Heated Tubing |
Additional Comments: Phillips SystemOne w/ Humidifier for daily use. (Not listed above) Airmini for travel. |
Daily Driver (normally sans recall): Phillips SystemOne w/ Humidifier / DreamWear Nasal Cushion
Travel Unit (now currently daily driver during recall): ResMed Airmini / AirFit P10
Travel Unit (now currently daily driver during recall): ResMed Airmini / AirFit P10