Philips Respironics Recall V2.0 Questions and Answers

Dog Slobber · Post by **Dog Slobber** » Sun Nov 07, 2021 11:57 am

packitin wrote: ↑
Wed Nov 03, 2021 1:14 pm

You may have me mixed up with someone else --- not at all rich, much less filthy, at least most of the time.

ChrisD · Post by **ChrisD** » Mon Nov 08, 2021 10:10 am

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

palerider · Post by **palerider** » Mon Nov 08, 2021 1:01 pm

ChrisD wrote: ↑
Mon Nov 08, 2021 10:10 am
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.

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.

ChrisD · Post by **ChrisD** » Mon Nov 08, 2021 1:26 pm

palerider wrote: ↑
Mon Nov 08, 2021 1:01 pm
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.

LOL, I can believe that.

Thanks.

Chris

ChicagoGranny · Post by **ChicagoGranny** » Wed Nov 10, 2021 1:03 pm

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Stephen750** · Post by Stephen750** » Wed Nov 10, 2021 1:05 pm

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.

Stephen750** · Post by Stephen750** » Wed Nov 10, 2021 1:13 pm

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.

GrumpyHere · Post by **GrumpyHere** » Sat Nov 13, 2021 6:45 pm

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.

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.

Holocron · Post by **Holocron** » Sun Nov 14, 2021 6:23 am

GrumpyHere wrote: ↑
Sat Nov 13, 2021 6:45 pm
TLTR: Silicone foam used for replacement program now suspect. FDA requests more testing.

This just gets better and better. Has anyone attempted to contact their government reps and/or state AGs?

ChicagoGranny · Post by **ChicagoGranny** » Sun Nov 14, 2021 2:08 pm

Holocron wrote: ↑
Sun Nov 14, 2021 6:23 am
Has anyone attempted to contact their government reps and/or state AGs?

WTH would you expect them to do that would be of benefit to anyone?

Grumpy48 · Post by **Grumpy48** » Sun Nov 14, 2021 7:56 pm

GrumpyHere wrote: ↑
Sat Nov 13, 2021 6:45 pm
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.

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????

ChicagoGranny · Post by **ChicagoGranny** » Mon Nov 15, 2021 11:42 am

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Grouchy Bear · Post by **Grouchy Bear** » Mon Nov 15, 2021 1:46 pm

This seems to be 'pretty much everything' in the category of PR machines:

https://www.youtube.com/watch?v=plC1aUPbcdw

kbh209 · Post by **kbh209** » Wed Nov 17, 2021 7:28 pm

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.

Holocron · Post by **Holocron** » Fri Nov 19, 2021 6:46 am

ChicagoGranny wrote: ↑
Sun Nov 14, 2021 2:08 pm

Holocron wrote: ↑
Sun Nov 14, 2021 6:23 am
Has anyone attempted to contact their government reps and/or state AGs?
WTH would you expect them to do that would be of benefit to anyone?

Not a damn thing. But it would make me feel better to have some investigation of the ineptitude.

Philips Respironics Recall V2.0 Questions and Answers

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