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

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MD+DI

Philips Pays $62M to Settle China Bribery Probe

Philips can’t seem to stay out of the headlines these days. The Amsterdam, Netherlands-based company will pay $62 million to resolve charges it violated the Foreign Corrupt Practices Act over its conduct related to sales of medical equipment to China, according to a report from Reuters.

According to the SEC’s order, Philips’ subsidiaries in China, cumulatively referred to in the order as Philips China, used special price discounts with distributors that created a risk that excessive distributor margins could be used to fund improper payments to government employees. The SEC’s order also found that employees, distributors, or sub-dealers of Philips’ subsidiaries in China engaged in improper conduct to influence hospital officials to draft technical specifications in public tenders to favor Philips’ products.

Philips Pays $62M to Settle (mddionline.com)

[TimaaaaaaaahRocks]

(all the above)

About time someone, not the company, was personally charged with murder. Seems one can easily get away with murder in the USA under the FDA's watch, not so much in the EU. Vive la France!

[eok361]

who believes the latest statement? or read the full test(s) results?

not me. just seeing if anyone did the work.

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drug watch

Philips Sets Aside $630M Ahead of Class-Action CPAP Lawsuits

In its first-quarter earnings report, beleaguered CPAP maker Philips Respironics announced it would set aside $630 million (€575 million) ahead of possible class-action lawsuit resolutions against the company.

Netherlands-based Philips reported a net loss of nearly $774 million, partially due to restructuring efforts and the aftermath of the 2021 recall of 5.5 million Philips CPAP machines in the United States.

Philips Sets Aside $630M Ahead of Class-Action CPAP Lawsuits (drugwatch.com)

[coldengrey]

(They have 1000 people working to recover the business....yet they are incapable of notifying customers or responding to emails from the FDA. The United States Federal Food, Drug, and Cosmetic Act appears to be a joke at PR.)


https://www.fda.gov/media/156811/download

“We are very intent on getting the sleep business back in play and we are expecting to be able to allocate some production capacity to that in the fourth quarter,” he said. “Of course, then we have to rebuild our pipeline inventory, but we have a team working on the recovery of the business as we speak.” That team comprises more than 1,000 people working under the leadership of Roy Jakobs, a member of the executive committee, van Houten says. 

“We’ve also made organizational changes throughout 2021, which include onboarding new top management in the Sleep and Respiratory Care business and further strengthening our quality and regulatory affairs leadership,” he said. 

Yes, I BELIEVE this is what's prompted one of the 23/26 counts of NEGLIGENCE.
   The conspiring to withhold (failure to notify) in order to stall until (sic) drub statens 2 market ready.
Then to FURTHER ENRICH THEMSELVES WITH THE WANTON NEGLIGENCE (EVIDENCE THEY PURPOSELY DID WANT THEY WANTED, KNOWING FULL WELL.
   Check out judge conti's master western Pennsylvania court Records avail online!

[WakeUpTime]

Philips has been accused of involuntary manslaughter in a complaint filed in France late last week over faulty respiratory devices, including machines used for sleep apnea patients.

Finally.  

We'd all agree that mistakes happen, but when the highest level corporate executives deliberately withhold safety concerns from suppliers, authorized dealers and patient-consumers for 1-2 decades, that's considered criminal in some countries.  The executives involved at Philips however have since taken golden parachutes and/or early retirement, leaving stock holders (pension fund managers) continuing to pay the penalties.

Good on the French for being bold enough to call it for what it is.  Other countries will merely seek financial damages.

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ConsumerNotice.org


FDA: Number of Deaths from Recalled Philips CPAP Devices Rising

In the first quarter of 2023, there were 40 deaths and more than 6,000 medical device reports submitted to the FDA. The new report brings the total number of patient deaths to 385. 

“A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain,” according to the FDA.

FDA: Number of Deaths from Recalled Philips CPAP Devices Rising (consumernotice.org)

[TimaaaaaaaahRocks]

In its first-quarter earnings report, beleaguered CPAP maker Philips Respironics announced it would set aside $630 million (€575 million) ahead of possible class-action lawsuit resolutions against the company.

How much ISO 10993 compliant biocompatible foam can you buy with $630,000,000?  A $hit-ton.  Perfectly predictable outcome when bean counters make design decisions AND nobody had the cahones to make it right. They are still making excuses for this atrocity on Murry Ridge Lane. 

*golfclap*

[robsmuir]

A humorous story about my experience with the PR recall…

In February, I received two new Dreamstation 2s with instructions on returning my older System Ones. There was enough room to send back yet an even older CPAP that had been collecting dust in a closet–probably at least ten years older. I certainly would never use it again, so I sent it back with the two DS2, figuring that they could dispose of it too.

Today, July 3rd, I got a beat-up package delivered to my door which contained the very old CPAP. Sheesh.

It has been unceremoniously dropped in the trash.

My Dreamstation 2s are working just fine.

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New e-mail from Philips:

Philips 

Philips Respironics DreamStation Go Remediation


We’re reaching out to you because you have registered a Philips Respironics DreamStation Go CPAP device in response to the voluntary recall of certain CPAP, BiPAP, and mechanical ventilator devices.

There are two options for remediation that are now available to you.

OPTION 1 - Financial payment for the return of affected units: You can select the financial payment option in the Patient Portal to receive $500, based on the manufacturing date of your affected device. 

OPTION 2 – Elect to receive a replacement device: If you elect to remain in the remediation course, you must make the selection in the Patient Portal. You may need to provide a current prescription and will be notified in the Patient Portal if that is the case. If you are unable, for any reason, to provide us with your current device therapy prescription, you have the option to receive a replacement device with automatically adjusted settings more commonly known as Auto-adjusting CPAP. You can learn more about Auto-adjusting CPAP settings here.

I quickly replied for Option 1