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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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RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Sleeprider - 05-23-2021
UPDATE: The Notice of Potential Product Defect has been updated to a Recall. A copy of the Recall notice can be found at this link: Philips Respironics Dreamstation Recall
3-9-2022 EDIT: If you've already registered your recalled machine with Philips, you can check the status of your recall at the Philips Recall Portal.
Quote:ADMIN NOTE:
A summary of basic recall information is included in this Wiki Article:
(that article includes a list of actions users may wish to take)
Quote:PLEASE HELP US - If you've already registered your recalled machine at the Philips website and you have ALREADY received a replacement machine from Philips-Respironics, please VOTE in this poll, and post a reply to comment on specifically WHEN you registered, WHEN you received the replacement, and WHAT KIND of machine was sent to you.
The poll is here:
http://www.apneaboard.com/forums/Thread-Philips-Respironics-Recall-Replacement-Tally
This notice of a potential product defect of both sleep positive air pressure and respiratory positive air pressure devices is transcribed without alteration from the Philips Respironics. Sound abatement foam around the pneumatic block (fan) may degrade and be drawn into the patient circuit. Philips Respironics is notifying consumers and customers, but not recalling or replacing any equipment, however the company has released the Dreamstation 2 which does not have the issue. It should be noted that Philips has encrypted the data on new machines in a way that OSCAR 1.3.1 could not support the devices, however the development team has released OSCAR 1.4.0 which can now read the encrypted data. Website: https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.
Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of Philips sleep and respiratory care devices currently in use. The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone*, and certain environmental conditions involving high humidity and temperature. Philips’ recently launched next-generation CPAP platform, DreamStation 2 is not affected.
To date, we have not received reports of serious patient harm related to this issue.
Philips takes this matter very seriously, and is working to address this issue for our customers and patients who rely on our sleep and respiratory care solutions.
* Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
What devices are impacted?
Sleep Products
- DreamStation CPAP
- DreamStation BiPAP
- DreamStation ASV
- DreamStation Go CPAP
- DreamStation Go APAP
- OmniLab Advanced Plus(sleep lab) CPAP
- 50 Series CPAP
- 50 Series ASV
- 60 Series CPAP
- 60 Series ASV
- Dorma 400, Dorma 500, & REMStar SE Auto CPAP (value line)
Respiratory Products
- DreamStation AVAPS/ST
- C Series AVAPS/ST
- A 40/30
- Trilogy 100
- Trilogy 200
- V30 Auto (hospital use)
- E30 (hospital use)
What products are not affected?
Products not affected:
- Trilogy Evo
- Trilogy Evo OBM
- EV300
- Trilogy 202
- A-Series Pro and EFL
- M-Series
- DreamStation 2
- Omnilab (original based on Harmony 2)
- Dorma 100, Dorma 200, & REMStar SE
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
Products that are not affected may have different sound dampening foam materials, as new materials and technologies are available over time. Also, sound dampening foam in unaffected devices may be placed in a different location due to device design.
Are affected devices safe for use? Should affected devices be removed from service?
Affected devices may continue to be used in accordance with their instructions for use.
What is the safety hazard associated with this issue?
In accordance with the Philips Quality Management System, the company continues to review potential health risks related to this issue, for reporting as required under governing medical device regulations and laws.
Has Philips received any reports of patient harm due to this issue?
To date, Philips has not received reports of serious patient harm related to this issue.
Philips has received a small number of reports of low severity harms such as headache, cough, and throat irritation. There have been no reports of serious injuries or death associated with this issue.
How many devices are affected? Is this worldwide?
This issue affects devices worldwide.
How will Philips address this issue?
Philips takes this matter very seriously, and is initiating actions to mitigate possible risks to patients.
Are there any steps that customers and/or clinicians should take regarding this issue?
Philips will provide further information to customers and clinicians as part of our ongoing preparations to mitigate this issue.
RE: IMPORTANT NOTICE PHILIPS DREAMSTATION USERS - Sleeprider - 06-05-2021
Just in case you are researching what machine to buy, there are a lot of reasons to look at alternatives to Philips today.
Phillips has recalled their CPAPs and advises patients to discontinue use - Illorum - 06-14-2021
Phillips Press Release: https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-care-devices.html
FAQ From Phillips: https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-faqs-for-dme-hcp.pdf.pdf
Reuters Article: https://www.reuters.com/article/us-philips-recall/philips-recalls-some-3-4-million-cpap-ventilator-machines-due-to-foam-part-idUSKCN2DQ0BO
Reddit Thread: https://www.reddit.com/r/SleepApnea/comments/nzi3d6/philips_has_basically_recalled_all_of_their_cpap/
This affects all the most popular Phillips devices including the dreamstation, BiPAP, and ASV. It does not affect the new DreamStation 2.
Worldwide Callback of DreamStation 1 - GerardDirks - 06-14-2021
Hello
This Morning Philips announced a Wordwide Callback for about 4 Million of its Original DreamStation
This week I have a meetin with my advisor for a review of the last month and I will discuss about giving the Machine back. I read some reviews about the DreamStation 2 and it seems the newer one is not an item which will used by me (YouTube review of CPAP Reviews)
I am a new user of this machine and have some issue that it doesn't help for my Sleep Apnea
- my mouth is extremely dry after using the application
- after using the application I am more tired then before I start sleeping ?!?
- my Withings Sleep Analyzer still reports a Sleep Apnea between AHI 15-30, while the DreamStation reports only a max AHU of 5.9 over the last month. very confusing.
- it seems that the pressure of the CPAP, lowers the Sleep Apnea but prevents that enough O2 comes in my lungs/blood
I will also ask my Doctor if the CPAP is the correct therapy for my individual issues?
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
Latest on Philips Respironics recall of DreamStation - SleepyHenry - 06-14-2021
https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-care-devices.htm
You can google it or use above address to see where we are today.
"To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification."*
This statement bothers me. It seem PR is giving some of us a choice: Continue using your Dreamstation or stop using it. If you can not afford or can not get an alternative device...then decide if the risk of cancer from the broken foam is less than the cardiovascular-Respiratory and Neurodegenerative complications that one can get from sleep apnea? Uhmm...hope that I am reading this incorrectly?
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - koala1 - 06-14-2021
There is no info on Japanese site and I wonder if I want to ask directly.
They would definitely exchange it for newer model but I couldn’t use oscar then…
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - A KLERK - 06-14-2021
Also in the Netherlands the mess has broken out ApneuVereniging considers what to advice...
PHILLIPS DEVICE RECALL?? - JoeyC - 06-14-2021
Has anyone heard of this recall that was announced this morning? If so does anyone have any more detailed info as to the reasons for the recall?
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update?fbclid=IwAR32D8Hr-U3arqWpxu18btJXrnPlrVk19kDc8NVAsRB7IU23X-5mf4YeTR8
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - cathyf - 06-14-2021
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.
RE: Phillips has recalled their CPAPs and advises patients to discontinue use - SarcasticDave94 - 06-14-2021
Respironicarcinogens 2 out soon. They should be ashamed, but they're too rich to care anymore.