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

[btreger]

Right-click on the post number, upper right of the post, that you want to reference.  Select "Copy Link".  In your new post, add "Insert a link" and paste the URL in the popup box.  You will have the option to name this link shortcut, something else like, "[Reference Post]".

I have done this for you post above:
Test link - Click on me!

Thank you

[btreger]

http://www.apneaboard.com/forums/Thread-...#pid431592

This is a test, sorry

[WakeUpTime]

"Philips expects summer recovery from supply chain woes"
Reuters  |  January 24, 2022
https://www.reuters.com/technology/phili...022-01-24/

AMSTERDAM (Reuters) -Dutch health technology company Philips said on Monday it expects sales to recover strongly in the second half of the year, while a steep decline due to global shortage of parts is likely to persist in the coming months.  Philips earlier this month warned that supply chain woes would hit profit and a ventilator recall needed to be expanded, sending its shares down over 15% on their worst day on the financial markets in decades.  "We expect to start the year with a comparable sales decline, followed by a recovery and strong second half of the year," Chief Executive Officer Frans van Houten said in a statement.

Philips has set aside 725 million euros ($820.41 million) to repair and replace some 5 million devices worldwide, but that sum does not cover the possible costs of litigation, with the company facing more than a hundred class action suits. 

Fears of a large claims bill already lopped around 15 billion euros off Philips' market value in the past nine months.

"Philips prepares for rocky start to 2022 after ventilator recall knocks €719M (US$814M) off 2021 income"
https://www.fiercebiotech.com/medtech/ph...it-at-2021
January 24, 2022

The recall recently grew to comprise about 5.2 million machines in use around the world. Philips began its repair-and-replace program for the devices in September and said this month that it had already manufactured 1.5 million repair kits, approximately half of which have reached customers.

In its full-year financial report, Philips said it’s on track to close out the repair program sometime in the fourth quarter of this year. After that, the only loose ends of the recall left to tie up will be those regarding the many class-action and personal injury lawsuits that have been brought against the company because of the recall, the financial impact of which Philips said it was still unable to estimate.

Unless I'm mistaken, I believe the reference to approximately 750,000 repair kits being in the hands of customers world-wide, uses the term "repair kits" loosely.  I believe it also includes new DS2 replacement devices.  The number also includes the replacement/repair of faulty invasive ventilators.

[TimaaaaaaaahRocks]

Even with the most recent drops in the stock price it still looks like a good one to short into oblivion. The worse financial news is yet to come as they are going to get slaughtered in the 100+ defective product lawsuits. They can't possibly be considering going into court and defending themselves given what has already been made public; hiding a safety problem from the public and FDA are rather serious charges. Going to have to settle outside of court. In some cases with the relatives of the dead patient. Icky. 




Is it 5 million devices or 15 million devices? 

From the recent FDA inspection: "Your firm is currently conducting on-going, Class 1 medical device recalls of over 15 million Philips Respironics ventilator, CPAP, and BiPAP devices, due to polyester polyurethane foam degradation and volatile organic compound emission, which was publicly announced on 06/14/2021" 

I know they originally tried to weasel out of recalling ALL of the products that use killah-foam and limit their exposure to just the USA. Does 15 million represent the total number of shipped products with killah-foam?

The repair bill for 5 million devices should be considerably higher than $820,000,000.....Wow! that is a lot of zeros.      Comes out to $164/each. They must be assuming they will never have to replace each and every device. They may have some extra cash on hand. I have to believe payroll dropped considerably on Murry Ridge Lane after the FDA inspection hit Franz's desk. 

Has anyone seen PR's response to the FDA inspection? I thought one only had 15 days to respond, in writing, to the Form 483.

[btreger]

This is the only article that comes close to finding out what Philips's response may be. There has been no reporting from the FDA or Philips. Of course, we can not know if they submitted a written response unless one of them reports it. 

I think it is way past the time that the FDA should be leveling heavy fines for failure to comply.    



This includes info on silicone testing

[btreger]

MEDTECHDIVE

Philips targets Q4 2022 end to recall as supply chain issues drag down results
Published Jan. 24, 2022

"We have submitted a comprehensive response to the November 2021 Form 483 as well as a detailed action plan to the FDA," Philips CEO Frans van Houten said on a conference call with investors to discuss the fourth-quarter results. "We have been able to increase production for the recall significantly. We are currently running at a triple rate versus last year. We have a further intent to raise that."

Some new information came out today:

Philips targets Q4 2022 end to recall as supply chain issues drag down results | MedTech Dive

[btreger]

Koninklijke Philips N.V.'s (PHG) CEO Frans van Houten on Q4 2021 Results - Earnings Call Transcript

Koninklijke Philips N.V. (NYSEHG) Q4 2021 Earnings Conference Call January 24, 2022 4:00 AM ET

Company Participants

Leandro Mazzoni - IR

Frans van Houten - CEO

Abhijit Bhattacharya - CFO

Conference Call Participants

Veronika Dubajova - Goldman Sachs

Hassan Al-Wakeel - Barclays

Kate Kalashnikova - Citigroup

David Adlington - JPMorgan

Lisa Clive - Bernstein

Ed Ridley-Day - Redburn

Julien Dormois - BNP Paribas

Delphine Le Louet - Societe Generale

Sezgi Oezener - HSBC

James Vane-Tempest - Jefferies

Wim Gille - ABN ODDO


Frans van Houten

Let me now speak about the Respironics recall. 

I would like to reiterate that we have strong program management in place to ensure the corrective actions related to the recall are completed as fast as possible. We have a competent team of over a thousand people working under the leadership of Roy Jakobs who is a member of our Executive Committee. We've also made organizational changes throughout 2021 which include onboarding the new top management in the Sleep & Respiratory Care business and further strengthening our equality, our regulatory affairs leadership for the Group, the Connected Care, and the Sleep & Respiratory Care business.

Importantly we have submitted a comprehensive response to the November 2021 Form 483 as well as a detailed action plan to the FDA. Philips Respironics continues to engage with the FDA and we will work closely with the agency to clarify and follow up with the inspectional findings and its requests.

Koninklijke Philips N.V.'s (PHG) CEO Frans van Houten on Q4 2021 Results - Earnings Call Transcript | Seeking Alpha

[TimaaaaaaaahRocks]

This is the only article that comes close to finding out what Philips's response may be. There has been no reporting from the FDA or Philips. Of course, we can not know if they submitted a written response unless one of them reports it. 

I think it is way past the time that the FDA should be leveling heavy fines for failure to comply.    

This includes info on silicone testing

Thank you. I read the Earnings Call Transcript, dude is a wee bit clueless. Ya think Franz is tired of hearing the word 'respironics'? Every analyst on the call asked something about PR. I suppose we'll see PR's response to the FDA inspection as soon as someone makes an FOIA request. Which in PRs case happens to be quite often. 

This is downright incredible:

Franz: "Testing is also under way on the silicone-based foam that Philips is now using in replacement devices, per the FDA’s request. “I want to emphasize the silicone is safe and you can also derive (that) from the fact that the FDA said the recall and replacement can continue,” van Houten said. “I think it relates to a desire to have a strong rigor around this, but I want to emphasize that all of our own tests show that silicone is safe.”  

FDA: "No risk analysis, health hazard evaluation, or design review was documented as a result of an A Series CPAP device, containing silicone foam, failing Volatile Organic Compound (VOC) testing as part of ISO 18562-2 and 18562-3 testing. Test Report Number 600253-RP-12 (Rev A), dated 08/24/2021, documents that an A Series CPAP device failed VOC testing as part of ISO 18562-2 and 18562-3 testing. Test Report Number 600253-RP-12 (Rev A) documents that [(1:5) (4~ compounds of concern (COCs) were identified, and rH4 ~ compounds were confirmed, due to their carcinogenic/mutagenic properties. Additionally, Report Number 600253-RP-12 (Rev A) documents that pediatric patients would potentially be exposed to higher concentrations of compounds of concern, if they utilized an A Series CPAP device for sustained periods of time. No health hazard evaluation, risk analysis, or design review was documented by your firm."

Me: Shaking my head. So PR plows ahead with the silicone replacement foam game without FDA approval, with internal testing that shows it is not safe, and without a risk analysis or design review. Failed to do a design review on an a revision to a recalled device...Wow. And Franz tells the world, hey we're all good, 'cause the FDA hasn't stopped us. (The FDA said the recall and replacement can continue? Seems rather unlikely.) Shaking my head. As I short the snot out of their stock.

[Kyteflyer]

Being from Australia, and following this thread, you might already have seen a previous post by btreger with the update link...

https://www.tga.gov.au/alert/philips-recall-action-cpap-bi-level-pap-devices-and-mechanical-ventilators

There's a Philips 1-800 number for Australia in there.  It's for setting up replacement devices but you could also challenge them with additional questions to see how they'll respond.  

There's also this under the section "Consumer and regulatory updates" (Australia):

I don't know if you've previously tried poking around those channels to see what they say these days, for Australians waiting for fixes/replacements.

Thanks for the link, I had not looked after I registered, initially, and I have heard nothing more.  I’m just thinking at this stage that I’m going to change brands, and abandon Philips entirely.  I’m happy enough with my old REMStar Auto, but a more recent device with an SD card and Oscar compatibility is more appealing.  I guess its a new “other” machine for me, this year, and the DS to the trash.

[sawinglogz]

The FDA said the recall and replacement can continue? Seems rather unlikely.

The FDA actually did say that. Their assessment was that the possible risk of the silicone foam was outweighed by the known risk of continued use of the PE-PUR foam or going without therapy. The FDA is still forcing Philips to retain an independent firm to confirm the safety of the silicone foam, because of that early report that Philips never addressed.

If it turns out the silicone foam does have problems, the FDA would then force Philips to do a recall of the fixed/replaced machines as well.