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

[btreger]

Also in Australia, I have an 11 year old REMstar Pro registered for replacement.

With consumer protection laws so strong in Australia you are entitled to get a cash refund, so why would you wait on Philips for anything?

Just curious......

[TimaaaaaaaahRocks]

(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. 

[chasmm]

I'm not absolving Philips of any of the blame on this...but how can a DME/supplier be UNAWARE of the recall? My own opinion...and it is just that...is that those 28 supplies are just sticking their head in the sand and going "recall, what recall? Philips never said anything about that, and this is the first we've heard of it."

And I'm curious...who ARE those 28 companies? Is there a list somewhere? I didn't see one in the 6-page email sent to Philips by the FDA but I may have overlooked it.

And to clarify...that's 28 out of a sample of 182 out of all of the companies that provide CPAP-related equipment...

[TimaaaaaaaahRocks]

I'm not absolving Philips of any of the blame on this...but how can a DME/supplier be UNAWARE of the recall? My own opinion...and it is just that...is that those 28 supplies are just sticking their head in the sand and going "recall, what recall? 

Right. Watch TV for a few hours a week and you'll see more than one "join our Respironics recall lawsuit" commercial. 

DME/suppliers have a good rational for sticking their heads in the sand. They are on the front lines of the recall dealing with confused customers. They won't get reimbursed by respironics for time spent dealing with this mess. In some cases they maybe liable if they failed to act on customer complaints. 

Caveat-venditor! Push garbage products on your customers and you both may pay the price.

[Jerry Sends]

I am in the US.  Got ahold of a Resmed Airsense A10 as a replacement, but I thought I would call to get an update from Phillips as my old device was registered in November. 

Per the customer service person:
"Your order has not been processed yet, we have until the end of this year to replace these machines."  "You will be updated once this is processed "

I now understand why the FDA is following up with this recall action.

[hegel]

As has been pointed out earlier: PR is on the hook for replacing millions (!) of defective machines worldwide. Covid has and is playing havoc with production and assembly processes. It's no simple matter to magic up some millions of machines and ship them worldwide. All of this needs to be factored in to the whole mess. So does our modern expectation to have instant fixes. Yes, millions are being inconvenienced and worse. The extent of the medical issues is still unknown. PR messed up badly. Perhaps they should have issued refunds to all affected persons, but that would have still left a massive shortage of machines world wide. But this would have been a 'quick (non) fix'.

Everyone would still be complaining.

[WakeUpTime]

Ouch.  I have two Philips Recalled devices that were registered back in June 2021.  Just did a status update at Philips.  Confirmation number became "not valid" on one of my two Recalled devices.  Checked serial number and got a "not registered", confirming that my initial confirmation on that device had later been deleted from Philips' database.  So, I had to re-register the device again and have returned to the bottom of the queue.  After almost 12 months, I didn't seem any closer to getting a fix/replacement anyway.

Thanks Philips for your incredibly poor quality of end-user support; and this is what Philips calls giving the Recall their "top priority"?  What Philips says, and what Philips does, seem very mis-matched.

[TimaaaaaaaahRocks]

As has been pointed out earlier: PR is on the hook for replacing millions (!) of defective machines worldwide. Covid has and is playing havoc with production and assembly processes. It's no simple matter to magic up some millions of machines and ship them worldwide. All of this needs to be factored in to the whole mess. So does our modern expectation to have instant fixes. Yes, millions are being inconvenienced and worse. The extent of the medical issues is still unknown. PR messed up badly. Perhaps they should have issued refunds to all affected persons, but that would have still left a massive shortage of machines world wide. But this would have been a 'quick (non) fix'.

Everyone would still be complaining.

It is no simple matter to magic up some millions of defective machines and ship them worldwide for several years but PR managed to pull it off. Shipping hazardous materials in the air circuits of millions of devices is completely beyond comprehension. PR profited handsomely off non-complaint machines for years while ignoring customer complaints and the procedures and processes outlined in the United States Federal Food, Drug, and Cosmetic Act.  

Had PR developed, tested, and supported products in compliance with US law there would be no need for anyone to complain. FDA is just as culpable as PR, hence their kid-glove handling of the situation. The penalties outlined in the FDCA are there for a reason. PR has met the bar for disqualification from the marketplace. 

To arrive at a disqualification, the federal agency must take several steps. First, based on inspectional findings, the agency needs to issue a Form 483 of observations of deficiencies. Second, failure to correct the deficiencies is followed by a Warning Letter. If the concerned party fails to take appropriate corrective actions, the FDA determines that disqualification is the proper solution. Consequently, the FDA will publish a public notice of the proposed disqualification action. Once the disqualification process is completed, the agency publishes its final decision in the Federal Register.

Time the FDA grew a set and start protecting patients and the integrity of the US medical device marketplace. Punitive damages exist for a reason. Hey man, if shipping $1B+ worth of non-complaint medical devices doesn't qualify an entity for disqualification what the heck does?

[SuperSleeper]

If the FDA attempts to disqualify Philips from entering into the CPAP marketplace, that would eliminate a major incentive they have to replace affected machines during this recall.  They could simply say, "If you're kicking us out of the market altogether, we'll simply quit distributing replacements and have our Respironics division declare bankruptcy and call it a day.".

It's their hope for future profits that keeps them engaged in this recall effort.

[Crimson Nape]

I've been expecting Philips to declare that division insolvent and close it down. It is far cheaper than all the pending litigation from every country in the world. Within a few months, you will see a new brand of CPAP on the market under some catchy name.