Apnea Board Forum - CPAP | Sleep Apnea
[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Printable Version

+- Apnea Board Forum - CPAP | Sleep Apnea (https://www.apneaboard.com/forums)
+-- Forum: Public Area (https://www.apneaboard.com/forums/Forum-Public-Area)
+--- Forum: Main Apnea Board Forum (https://www.apneaboard.com/forums/Forum-Main-Apnea-Board-Forum)
+--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS)



RECALL THREAD - WakeUpTime - 10-20-2021

(10-20-2021, 02:06 PM)btreger Wrote: << contributions >>

Couldn't help but notice that your post contribution was the 1,600th post in a 160 page thread.  Someone early on mentioned that this thread should be made a sticky thread. I think it was Sleeprider that chimed in that it wouldn't need to be, because of all the interest that it would generate - it would likely remain near the top.  He was right of course.  It's likely to become one of the top thread views of ApneaBoard as a result of the Recall's impact on so many of Philips' present and past device users.  With at least another 12 months of deliveries and service-fixes, news articles, lab reports and legal activities, both in the U.S. and abroad, it should continue to be of interest to many.  Incidentally, it's been 5 months since Sleeprider first started this thread, back on May 23rd.


RE: RECALL THREAD - btreger - 10-20-2021

(10-20-2021, 03:26 PM)WakeUpTime Wrote:   Incidentally, it's been 5 months since Sleeprider first started this thread, back on May 23rd.

Only 5 months. It feels more like 2 years. I still think there is 1 article out there that will blow all this up, and answer all our questions. That thought is what keeps me going........


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - GWild - 10-20-2021

I just received notice my machine may be repaired or replaced within a year. Oh, they also informed my using a bacterial filter was not recommended. Whoopee! I have to suffocate myself while waiting for a working machine!

Well - not gonna happen. AHI is under 2 using a filter. My machines are well past any VOC concern - any outgassing happened years ago. So particulates would be my main concern, and a filter that seems to not preempt functional positive airway pressures is a no brainer. APAP range is still not peaking at 20, and median pressure is only slightly above my unfiltered norm, so the machine isn't having issues, either.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - jpsantell - 10-20-2021

Sorry, I can't see the email nor have I received it either could you tell me what it said?


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - GWild - 10-20-2021

My latest looked like this:

=================
We are pleased to share an important update regarding your Philips device replacement. Philips received authorization from the US Food and Drug Administration (FDA) for the repair and replacement program for devices impacted by the June 14, 2021 recall notification*.
 
With this approval, we are initiating the repair and replacement program that puts patient safety and speed of resolution as the top priorities. Further, we have significantly increased our production, service and rework capacity to deliver replacement devices as fast as possible.

Also, we have learned of some fraudulent activity targeting patients impacted by this recall. We want to assure you that Philips will never ask for any payment or credit card information by phone or email.

Patient care is at the heart of everything we do at Philips. While we are starting to replace devices, in some cases, this process may take approximately 12 months. We will stay in communication with you regarding your replacement device. If you have already received a replacement device, please follow the instructions included in the box.

We appreciate your patience as we work towards a solution as fast as possible. Please visit  Philips.com/src-update for more information and answers to frequently asked questions.

As a reminder, your device registration confirmation number is 20210912xxxxxx.

Thank you for your continued trust.  Thumbs-down-1
 

*This is a recall notification for the US only, and a field safety notice for the rest of the world. In the US, the recall notification has been classified by the FDA as a Class I recall. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices.
** For more information and continued updates, visit philips.com/src-patient-information.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 10-21-2021

The Philips Recall Just Doubled! 10,000,000 Machines Affected


This is Nicko's video recap of the Financial Times article I posted yesterday, enjoy.

https://www.youtube.com/watch?v=UmGy7_khBF0


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - cbeissel - 10-21-2021

Here is the Australian version of the letter.

It contains almost zero information.


Update on the Philips Urgent Product Defect Correction

[Image: image.jpg?v=undefined]


[size=undefined][size=undefined][size=undefined][size=undefined][size=undefined][size=undefined]
 
We are reaching out to share an important update on the Philips Urgent Product Defect Correction regarding registered affected Philips DreamStation devices.  
Thank you for registering your device information with Philips.  
As a reminder, your device registration confirmation number is 202107030501XXXX.
We are writing to let you know that the repair and replacement plan in Australia is underway and manufacturing of DreamStation devices has commenced. Philips has begun contacting registered patients and customers with instructions on the next steps of implementation for these DreamStations. If your contact details change, please let us know.
Due to the volume of devices and different models that are affected, we regret it may take some time to repair or replace all affected devices. In addition to the Dreamstation devices, Philips will provide further updates on other affected models. 

Patient care is the heart of everything we do at Philips. We appreciate your patience as work continues on the repair and replacement program. 
We will continue to share updates and additional information regarding progress with you via email, as well as on Philips.com/src-update
Please note that we have been made aware of fraudulent activity targeting patients impacted in other countries related to this Urgent Product Defect Correction. We want to assure you that Philips will never ask for any payment or credit card information by phone or email.
Thank you for your continued trust.
[/size]
[/size]
[/size]
[/size]
[/size]
[/size]


[size=undefined][size=undefined][size=undefined][size=undefined][size=undefined][size=undefined]
Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you.  [/size]
[/size]
[/size]
[/size]
[/size]
[/size]



RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - ST Dog - 10-21-2021

(10-20-2021, 04:47 PM)GWild Wrote: My machines are well past any VOC concern - any outgassing happened years ago. So particulates would be my main concern, and a filter that seems to not preempt functional positive airway pressures is a no brainer. 

my understanding was the degradation leads to off gassing, well after the normal off gassing of new items.


VIDEO SUMMARY OF FT INTERVIEW - WakeUpTime - 10-21-2021

(10-21-2021, 01:34 PM)btreger Wrote: This is Nicko's video recap of the Financial Times article I posted yesterday, enjoy.
https://www.youtube.com/watch?v=UmGy7_khBF0

He really does a good job of cutting through the political speak from Philips.  He makes the point that just because your device isn't being recalled doesn't mean it doesn't suffer from the same faulty foam.  Some owners of older systems are relieved to know that their system isn't being recalled. Philips is just choosing not to deal with those other machines.  Philips is misleading the public on that point.  In fact, up to 10 million machines are ultimately affected by the faulty foam. 

Philips has still yet to determine which recall registrants will actually get a replacement machine/fix.  Yes, you heard that right!  Just because you have a confirmation number apparently isn't enough to ensure you get a replacement/fix.  Philips is choosing "active users" for replacement/fixes, not all users including those who have shelved their faulty foam recalled system.  That's really terrible, in my opinion.  If people have purchased replacement machines and still wanted to keep their old Philips machine as a backup, they should be allowed to have it foam-updated.  Imagine for a moment if any other recalled product manufacturer tried to invoke that option - only replace products that are being actively used at this moment.

Lawyers should be taking note of these Philips statements for their class-action lawsuits.  Philips is giving them lots of new material to work with.  I hope they update their actions against Philips, on behalf of all Philips device owners.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - chasmm - 10-22-2021

I thought the Facebook post quoted below might be of some interest. It's from the "Original Philips Dreamstation Recall Support" Group. In it a member posted a picture of a DS1 (without the humidifier) and stated that he had received it from Philips.

It seems to be the first "known" instance of someone getting a DS1 as part of Philips replacement program.

In follow-up questions, he answered:
  1. It is a CPAP, not a BiPAP
  2. There is no indication anywhere about whether it is NEW with New Foam, NEW with No foam, REFURBISHED with New Foam, REFURBISHED with No foam
  3. The only date on the bottom says 07-23-2021
  4. He has NOT responded to requests to check the serial number against the recall list
  5. He has NOT responded to requests to check the blower hours, etc.
The post is in full below:
Quote:Today I received this piece from Philips with instructions to return the old unit.  The return instructions say "[t]he enclosed DeamStation machine is provided to you as a replacement for your existing DreamStation. To ensure proper disposal of your current machine, please return the affected machine followlng the instructions below."  Though I havent't read through the supplied User Manual (which looks like the original manual), l have reviewed the other papers included in the box and NOWHERE does it say that this unit is ANY DIFFERENT from the original units containing the foam that led to the recall.  Philips has provided me with no indication at all that this unit is any safer to use than my original recalled unit.  If anyone has received this type of replacement from Philips and has reason to believe that it is safer than the recalled unit I would be interested in hearing the basis for your belief (other than that Philips has said this replaces the existing one).  Oh, and I have no intention of mailing back the recalled unit (i.e., relinquishing evidence proving that I am a member of the yet-to-be-filed class action suit against Philips) even though they would pay the postage.