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+--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS)
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RE: Phillips has recalled their CPAPs and advises patients to discontinue use - Gideon - 06-14-2021
This massive of a recall is unprecedented. I can only conclude that their internal data indicates a significant risk, both to your physical health and to PR's financial health from legal actions against them in addition to anticipating a forced recall from the various governments of the world..
Actions
1 get a new machine, either via the recall or otherwise,,,,
2. Stopgap until you can get a new machine, use an online antibacterial filter to stop particles from going into your lungs. Note this will do nothing to stop the gasses they talked about.
RE: Worldwide Callback of DreamStation 1 - Melman - 06-14-2021
(06-14-2021, 05:39 AM)GerardDirks Wrote: If I will go further with CPAP, what is the best machine available (comfort, operation, effect). I suppose, because of this Callback of Philips, I will have a right to switch the machine to another brand?
Regards
Gérard
The best machine is the Resmed Airsense 10 Autoset or Autoset for her. Be aware their are several Airsense 10 models. The autoset is the one you should get. We have found that it provides better therapy than the dreamstation
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - EngineerBoo - 06-14-2021
Dang, I'm going on one year with my DreamStation...this sucks! I have noticed that my seasonal allergies this year have been the worst ever...had a sinus infection in April. I emailed my CPAP provider and she's checking my machines serial number with Philips and asking what to do. I've lost trust in Philips and hoping to get a Resmed Airsense 10 issued. (I'd even pay for it if I have to.)
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - cathyf - 06-14-2021
Another thing that's going to happen is that this is going to cause a world-wide shortage of not-Phillips blowers. We are going to have to fight over who's going to get the new Airsense 11''s, all the way down the line to people grabbing the used machines so that they will have something.
Trust is one of those things that take decades to build and is gone in an instant.
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - pholynyk - 06-14-2021
For those of you who didn't read all the way down on the Phillips notice, it said:
* This is a recall notification for the US only, and a field safety notice for the rest of the world
Not sure what a 'field safety notice' is, but it sounds like a CYA relating to US law. The rest of world is on its own.
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - koala1 - 06-14-2021
(06-14-2021, 04:34 PM)pholynyk Wrote: For those of you who didn't read all the way down on the Phillips notice, it said:
* This is a recall notification for the US only, and a field safety notice for the rest of the world
Not sure what a 'field safety notice' is, but it sounds like a CYA relating to US law. The rest of world is on its own.
Not really. Just terminology.
FSN is pretty much recall
FIELD SAFETY CORRECTIVE ACTION (FSCA) (Europe MEDDEV 2.12-1): An action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions should be notified via a FIELD SAFETY NOTICE.
FIELD SAFETY NOTICE (FSN) (Europe MEDDEV 2.12-1): A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.
Per US FDA, CORRECTION means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product/device without its physical removal from its point of use to some other location.
Per US FDA, REMOVAL means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
RECALL (US FDA): The correction or removal of a device commercially distributed for human use in the US where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. Reasonable probability means that it is more likely than not that an event will occur.
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - TomR60 - 06-14-2021
US only - probably because we seem to have multitudes of attorneys that will sue at the drop of a hat.
I'm still going to call my DME tomorrow and insist that they swap the Dreamstation I've had for the past three months with a Resmed AutoSet 10.
I think it's going to be an interesting conversation...
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - Knightfire - 06-14-2021
(06-14-2021, 10:53 AM)cathyf Wrote: So they let users be potentially injured by this machine in the time period between when they found out about the defect and they decided to issue the recall.
And now they want us to trust that they won't lie about some potential defect that the DS2 (or aren't already lying about something that they already know about the DS2) ?!?
...I don't think so!
This is a medical device.
It's a device normally used in an environment where everyone in the room is unconscious and so can't monitor the operation for malfunctions or dangers.
Nope.
Not happening.
I am DONE with any consideration of using any PR device.
Recall of Philips CPAPs - JaneAM - 06-14-2021
Anyone new the best site to read about the recent recall of Philips CPAPs? I saw a Wall Street Journal article today saying they were being recalled because they've been identified as causing cancer in some users. Very interesting to me since I've been using a Philips Dream Station for 5 years and was diagnosed with breast cancer 6 months ago. I wonder what kind of cancer the study showed had been caused by the Philips CPAP? Interested in any and all referrals to updated info. I just called my doctor, who didn't seem to know about the recall.
RE: Recall of Philips CPAPs - gadgetmaniah - 06-14-2021
I think the most details are on Philips' own website. See here: https://www.usa.philips.com/healthcare/e/sleep/communications/src-update