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

[Phaleronic]

I too am exhausted waiting and had an ASV machine that was supposed to get repaired. I am tired of waiting and don't trust their machines anymore. Does the $50 deal still exist to get them out of my life?

Is it a DreamStation ASV? 

I can remediate it for you.

[Labromaniac]

Is it a DreamStation ASV? 

I can remediate it for you.

It was a system one

[ST Dog]

FIERCE

Biotech

FDA warns that Philips has fully fixed 'considerably' fewer recalled devices than the online tally may suggest

Now, about a year and a half into the repair-and-replace program, Philips’ website states that 90% of the production of all needed replacement devices and repair kits has been completed and that 2.46 million of the devices and kits have been “shipped in the U.S.”—but the FDA is taking issue with the latter figure.

FDA flags disparity in Philips' actual recall work, online tally (fiercebiotech.com)

So after a year of reporting the devices and kits number now the FDA questions it and doesn't give any indication of how many devices have been completed and how many are just repair kits.


In a statement sent to Fierce Medtech, Philips clarified that so far, about 2.2 million repaired or replacement devices have been shipped to U.S. consumers.

So Philips did give that, the FDA just didn't bother to include it.  So 10% is kits still in process.

Wonder how many kits are waiting for returned devices to be processed because thousands aren't bothering to return them.

[WakeUpTime]

My situation turned into a deadlock with Philips' independent contractor service representatives.

"Philips", through their contracted agency, upon achieving my"ready to ship" status, requested doctor contact details for an updated CPAP prescription.  For a current CPAP prescription, my doctor of course requires a visit, an updated sleep study, and a follow-up visit.  Basically TIME + MONEY, only to ultimately receive a used refurbished replacement with the "Philips" brand label that would cause me untrust and associated anxiety.  

So, lucky for Philips, I'm one faulty device owner (actually two) that they can ultimately write-off as in default of policies and conditions.  Just in time for the second anniversary of the April 2021 Philips Recall announcement.  Well played Philips.  You win.

[btreger]

New e-mail from Philips

This paragraph is of concern to me:

If you have registered a DreamStation Go device, please note there is no action with respect to the remediation at this time and we will address replacement device information in a future communication as well as in the Patient Portal.

[ST Dog]

For a current CPAP prescription, my doctor of course requires a visit, an updated sleep study, and a follow-up visit.

Weird.  I called my doctor and said I needed a copy of my Rx for the recall (that his office alerted me to withing days of it happening) and they faxed it over. Same as they do when I need a copy for supplies from online suppliers.

Of course I see him regularly to monitor treatment.


Then again, just select the auto option and set it up yourself. Even if you get the Rx, they (or whoever they hired) seem to have difficulty tracking it.

[ST Dog]

New e-mail from Philips

This paragraph is of concern to me:

If you have registered a DreamStation Go device, please note there is no action with respect to the remediation at this time and we will address replacement device information in a future communication as well as in the Patient Portal.

The Go is a secondary travel device, not a primary treatment device. They haven't started working on them yet. That won't happen until the primary devices are complete. I doubt the FDA wants them expending resources on secondary devices either.

I suspect they have a fix and a plan, but I doubt the FDA would give them a decision yet. Again, focusing on tne primary devices first.

[vxarctic]

Phillips had me ship them my unit six months ago back in November and they still haven't shipped a replacement. I've been struggling without my cap.

Is this normal? I would have expected them to have a replacement ready when they gave me the shipping information.

[ST Dog]

Phillips had me ship them my unit six months ago back in November and they still haven't shipped a replacement. I've been struggling without my cap.

Is this normal?

First I've heard of anyone shipping before getting replacement. Something sounds off.

What machine was it? Some advanced machine, like ASV or ST?

[vxarctic]

First I've heard of anyone shipping before getting replacement. Something sounds off.

What machine was it? Some advanced machine, like ASV or ST?

Respironics PR System One REMstar 60 Series Plus CPAP Machine