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

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ProPublica

Several weeks ago I posted this article:

Chemicals of “Concern” Found in Replacement Machines Raised New Alarm

After re-reading that article I found this link to a lawsuit it filed against the FDA for the release of data that Philips had provided concerning new test results that the FDA had requested, but not released.

ProPublica and the Pittsburgh Post-Gazette Have Sued the FDA for Records Related to Recalled Breathing Machines

The agency denied multiple requests by the news organizations to quickly release key documents submitted by Philips Respironics.

In its denial, the FDA estimated it would take as long as two years to produce the records.

After the lawsuit was filed in April, the FDA agreed to begin producing documents. The agency, however, fully redacted the company’s test results and assessments on the degrading foam — more than 1,000 pages 

The agency cited an exemption in FOIA law that protects trade secrets and commercial or financial information that could impact a company’s business interests.

ProPublica, Pittsburgh Post-Gazette Have Sued FDA for Records Related to Philips CPAP Recall — ProPublica

Notes of concern;

• The FDA estimated it would take two years to produce the records. Nicko has already demonstrated using AI tools in his video, that data can be produced and formatted in any format you want to view it very quickly. 
  
• The FDA cited FOIA laws that protect trade secrets and financial information.
  
• Nowhere does the FDA site the right of consumers to be protected from serious health consequences and death. It has been almost 2 years since the FDA requested Philips to do more testing on its silicone foam. We have never received any updated information on those test results. The only information we have is from news organizations.
  
• Many on this Thread and elsewhere have raised the question of whether the FDA is trying harder to protect large organizations than the people it has sworn to protect. 
  
• When the recall first started I thought I knew the answer to that question, today I honestly do not know.     
  

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BNN

Philips Countersues SoClean Over Recalled Breathing Machines

Koninklijke Philips NV has mounted a legal counteroffensive against SoClean Inc., refuting allegations related to a significant recall of Philips’ breathing apparatus. The unfolding legal drama underscores the escalating tension between the two entities over the recall debacle. Philips’ rebuttal emphasizes its stance on the compatibility of third-party products with its medical equipment.

Philips Responds to SoClean’s Allegations

In response to accusations by SoClean, Philips alleges that the former inappropriately blamed the recall of Philips’ breathing machines on issues stemming from SoClean’s ozone-based disinfection products. Moreover, Philips contends that SoClean diluted Philips’ trademarks by claiming their products were compatible with Philips’ medical devices without obtaining proper authorization.

Philips Countersues SoClean in Recall Dispute (bnnbreaking.com)

[Phaleronic]

Soclean is terrible, and I remember them being stacked all over the office of my first and only DME I used (about 7 years ago)-they even pitched it to me, I refused and am glad I did.

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PBS

NEWS
WEEKEND

Investigation finds new risks with Philips breathing devices after 2021 recall

In 2021, a widely used breathing device manufactured by Philips was the subject of a safety recall. Now, new reporting shows that the replacement machines sent out to customers might also pose dangerous problems. Ali Rogin speaks with Debbie Cenziper, one of the leaders of the ProPublica and Pittsburgh Post-Gazette investigation, to learn about the latest developments.

Note: You will find one video and audio link on this website.

Investigation finds new risks with Philips breathing devices after 2021 recall | PBS News Weekend

[Sheepish]

This make me feel somewhat lucky that the Philips dogsled has not yet made it up to Canada with the replacement DS2. 

[TimaaaaaaaahRocks]

Moreover, Philips contends that SoClean diluted Philips’ trademarks by claiming their products were compatible with Philips’ medical devices without obtaining proper authorization.

Sure....., cause every company wants to align themselves with Philips' great reputation.

What's next from Philips? The EuthanasiaStation III? - Shape it like a black coffin, pass a random amount of some known and unknown toxic chemicals into the air circuit, and toss a coin whether you'll experience a bedside "thermal event" while you're asleep. A complete crap design, and ineffective product compliance testing that failed to identify the deficiencies. 

Philips defends CPAP safety (in a letter to the editor?). Leslie McGibbon should be ashamed. 
https://www.post-gazette.com/opinion/let...2401070038

[WakeUpTime]

[PBS News Video] "Investigation finds new risks with Philips breathing devices after 2021 recall"

(Q) How did you find out about these problems that the new Philips machines are having?

(A) ...Sources shared test results that had not yet been made public, as well as internal records that showed that scientists working for the company were growing increasingly alarmed about the results on these new machines that showed that the machines were releasing chemicals such as formaldehyde.

The test results show that it (the new foam) is releasing chemicals, and that is what's causing concerns, not just by scientists within the company but also by the FDA.

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FDA


ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets Due to Possible Magnetic Interference with Certain Medical Devices

Recalled Product;
 
Product Names: AirFit and AirTouch masks
Product Codes: See Recall Database Entries: 

Class 1 Device Recall AirFit N10 (fda.gov)
Class 1 Device Recall AirFit F20 (fda.gov)
Class 1 Device Recall AirTouch F20 (fda.gov)
Class 1 Device Recall AirFit N20 (fda.gov)
Class 1 Device Recall AirTouch N20 (fda.gov)
Class 1 Device Recall AirFit F30 (fda.gov)
Class 1 Device Recall AirFit F30i (fda.gov)

Model Numbers: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i 
Distribution Dates: January 2020 to November 20, 2023
Devices Recalled in the U.S.: 20,414,357
Date Initiated by Firm: November 20, 2023

Device Use

The AirFit and AirTouch masks are non-continuous ventilatory devices, intended to be used by patients weighing more than 66 lbs. who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The masks are meant for reuse by one person at home or by multiple people in hospitals.

The devices have magnets on the lower headgear straps and frame connections of CPAP masks. These magnets are there to make wearing the mask more comfortable.

ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices | FDA

[sauerkraut]

Real nice of resmed to omit what kind of medical devices are effected !!
Although it is probably pacemakers and other devices with a control box
implanted in the upper chest ..

[PAPPER101]

Re: PHILIPS RESPIRONICS RECALL - Are we properly protected by the supposed "Government Safety" apparatus?

Greetings fellow PAPPERS:

I know that this is an OLD STORY with many twists and turns, but I wanted to try again to chime in with my POV.

May 1, 2019 - I delivered my "Formal Complaint" to the executives at PHILIPS Re: "Burning Odor coming from my PR-DRSTN CPAP Machine".
- PHILIPS was instantly in total denial and just brushed me off without even offering to conduct a defect assessment.

* This was about two (2) years prior to the official announcement of the "Recall".

As a result of the PHILIPS flagrant disregard for safety, at that time I also requested their MSDS Data on the machine components (i.e. Humidifier Chamber, etc.).
- PHILIPS refused to provide anything regarding their toxic VOC's lab tests except for the generic statement "Our equipment meets with all of the safety guidelines".

When I attempted to "Register" for the "Recall" via the PHILIPS Recall Registration Gateway the PHILIPS CSR demanded (as prerequisites) my consent to share my medical/data records with PHILIPS (in advance) and that I return the defective CPAP Machine to PHILIPS. - I refused both of these demands.

It seemed to me that our various Government's had already worked out a backroom deal, to help limit PHILIPS Liability.
- Why couldn't an affected patient/user be allowed to just add their name to the Class Action Claim via a local Law Firm?

* Why wasn't my local Law Firm (selected to "Re-Present" affected/injured parties) interested in seeing any of my formal correspondence with PHILIPS from 2019?
- Wouldn't such documentation (evidence) help to establish PHILIPS willful neglect, lack of due diligence and intent to cause harm?

Does anyone else suspect that "Health & Safety" (Re: safe standards for toxicity of Medical Equipment manufacturing) is not actually being regulated by the "Regulators"?

Does anyone else have concerns that use of a defective/toxic "Medical Device" for extended periods (i.e. 51+ months) could have some serious negative long-term consequences?
* Our Doctors here in Canada seem to have suddenly entirely forgotten how to properly diagnose a set of lungs for signs of scarring/damage due to long-term toxic exposure.

Does anyone else have concerns that use of "Insulating Foam" situated within the air-flow-way of these machines is problematic and ought to be avoided?

Does anyone else have concerns that the (non switchable) internal "Modems" within these "Medical" devices is a privacy & safety risk (i.e. cyber hacking).

- Special thanks to all of you who assist PAPPERS in making progress with this health matter.

Cheers!