[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[ger365]

Just got this...
Game Over! - Philips Recall & FDA Update #foamgate - YouTube

[ST Dog]

Just got this...
Game Over! - Philips Recall & FDA Update #foamgate - YouTube

Just a video discussing the FDA release a few days shim which was being discussed in the last page or two here.

[Sleeprider]

On November 12 the FDA released an inspection report in follow-up to the Philips recall. This report shows the new silicone foam fails VOC off-gassing tests with carcinogenic and mutagenic compounds detected, and expands the investigation of recalled products into the Trilogy ventilator line and others. I started a new thread here: http://www.apneaboard.com/forums/Thread-...ive-in-DS2

[btreger]

FDA questions safety of Philips replacement foam for recalled devices:

Published Nov. 15, 2021

FDA's request for further testing of the replacement sound abatement foam threatens to snarl Philips' efforts to rebound from the recall and regain market share. "We believe that the need for additional testing could slow Philips Respironics' effort to repair or replace its recalled units," Needham analysts said in a note to clients.

Philips, in a press release, said it will work closely with FDA to clarify and follow up on the inspection findings and the agency's request for comprehensive testing. The company's stock price was down 11% before the market opened Monday.

https://www.medtechdive.com/news/fda-phi...ed/610026/

[ger365]

You blow off to much, me tinks as others you are a plant for Philips !..There is new  PROVEN data here...grow up...

[SuperSleeper]

Folks, in the interests of keeping these issues organized and separate... since we now have two major issues

Let's use this RECALL thread to discuss the recall of the original DreamStation machines.

For discussion of the possibility of the replacement DS2 units having issues with the silicone foam in them, please use this thread:

http://www.apneaboard.com/forums/Thread-...ive-in-DS2

[btreger]

Let's use this RECALL thread to discuss the recall of the original DreamStation machines.

For discussion of the possibility of the replacement DS2 units having issues with the silicone foam in them, please use this thread:

I am having a little problem trying to understand the methodology that went into this decision. All DS1 owners would surely be interested in knowing that the foam in their new DS2, or soon-to-be new DS2 was being recalled. If that were to happen everyone would need to know. I do not see how you can separate (Philips and Recall) without important information being missed.

Please explain what I might be missing here.

Thanks

[Gideon]

Simply say it exists and point to the new thread.

[Sleeprider]

The reason I created a new thread, is that the DS2 machines appear to be defective, or need further testing to verify their safety. This is a different issue from the original recall. Also this thread is approaching a size that makes it unwieldy to find what has been posted. Time for a new thread that discusses the DS2 and any problem associated with the silicone foam, and legal issues that will likely arise from rushing the DS2 to market to resolve issues with the DS1.

[zymurgy42]

I had to call and request a replacement manually because my machine was made in the USA but I live in AU.  I have not heard a word since that day and it has been over a month now.  I have been look over or forgotten about.  I give up on getting a replacement ever.

Becky,

I also purchased my machine from US and shipped to Australia. I registered ONLINE and did eventually receive a confirmation of registration - I'm not sure of the time frame though.

Gordon.