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What is going on?! Philips Respironics Dreamstation Recall
#1
What is going on?! Philips Respironics Dreamstation Recall
I registered my recalled DreamStation on the Philips Respironics Recall website in the morning of June 17, 2021, which to my knowledge was the very beginning of when you could register your device.  It is now November 15, 2021, 5 months later, and not only did they not contact me whatsoever, but I still don't have my replacement machine.  I've seen people on this forum who were given a DreamStation 2 literally months ago.  What on earth is going on?  FIVE MONTHS?!  I confirmed on the phone just now they did in fact receive my registration for the recall on June 17th, however he couldn't provide any further details other than confirming my address.

Can anyone provide any insight, tips, etc?

I don't need a "workaround" in the meantime, I'm trying to get Philips to replace or repair my machine like they are supposed to under the recall.
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#2
RE: What is going on?! Philips Respironics Dreamstation Recall
Start with this new thread http://www.apneaboard.com/forums/Thread-...ive-in-DS2

The replacement machines use a silicone foam to replace the polyurethane foam in the recalled machines. Well, the FDA has ordered Philips to do more testing on that foam and raised a lot of issues concerning who knew what and when, and whether the replacements are even safe. All of this broke just over the weekend.
Sleeprider
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#3
RE: What is going on?! Philips Respironics Dreamstation Recall
5 months.... keep on waiting, it could be over a year!  Now there is talks that the foam in the DS2 may be a health risk too!  I removed my foam many months ago and haven't thought much about it since!
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#4
RE: What is going on?! Philips Respironics Dreamstation Recall
(11-15-2021, 05:31 PM)Sleeprider Wrote: Start with this new thread http://www.apneaboard.com/forums/Thread-...ive-in-DS2

The replacement machines use a silicone foam to replace the polyurethane foam in the recalled machines.  Well, the FDA has ordered Philips to do more testing on that foam and raised a lot of issues concerning who knew what and when, and whether the replacements are even safe.  All of this broke just over the weekend.

It appears a single test show higher than acceptable VOC's and none when Philips performed similar tests.  Certainly not a reason to run for the hills.  


Be aware that 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.
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#5
RE: What is going on?! Philips Respironics Dreamstation Recall
Speed3914, I hope you will also contribute in the new thread. Still too early to know how this will go, but hope to get some discussion on the new issue.
Sleeprider
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____________________________________________
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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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