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

[sauerkraut]

From the letter linked by btreger;
(Philips Respironics is committed to addressing this issue quickly and efficiently)

Like the foam recall ??

[Homerec130]

Medical conglomerates and insurers have deeper pockets to hire lawyers than most DMEs and private consumers. When the bigger dogs speak, they listen.

[sauerkraut]

Homerec130;
The consumer always gets screwed with these class action suits !!
but the lawyers make a bundle !!

[btreger]

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.

According to an update, the agency added Thursday to its webpage regarding the recall, “the number of replacement and remediated devices that have been shipped to consumers in the U.S. is considerably less than the 2,460,000 number of ‘new replacement devices and repair kits’ posted on Philips’ website.”

The regulator noted that the tally includes the number of devices that have been completely repaired or replaced and sent back to users and the number of repair kits that Philips has sent to facilities, which would still need to do the actual repairs on recalled machines.

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

[Bossofdos64]

From the FDA website:
www(dot)fda(dot)gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls

UPDATE - April 13, 2023: To provide transparency for consumers who are awaiting a replacement device, the FDA is clarifying that the number of replacement and remediated devices that have been shipped to consumers in the U.S. is considerably less than the 2,460,000 number of "new replacement devices and repair kits" posted on Philips' website. The 2,460,000 number includes manufactured repair kits that Philips shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers. We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device. We encourage consumers to contact Philips to get an update on the status of their replacement device. 

UPDATE - On April 7, 2023: The FDA classified Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy as a Class I recall, the most serious type of recall.

[HenryBowman]

So I got another notice in the mail today from Philips. This one says they're ready to replace the CPAP that's been coating my lungs in Real Glycerin Vibrafoam for the past three years while they "got around to it."

It says they want me to log in to their site and provide them my prescription therapy settings. As far as I know, that's a single pressure level setting.

They say if I can't provide this to them, they can send me an auto-adjusting CPAP that has default settings that provide what it thinks it detects you need as you sleep, or can be set to my prescribed settings "by a doctor."

They seem to be pushing the auto-CPAP option. "It allows us to fill your order faster without compromising your long-term therapy options." (Like breathing foam dust for the past three years while you dicked around? But whatever.)

The auto-CPAP sounds like a more flexible (and pricier) machine, but the not-so subtle pressure to choose it makes me think the advantage somehow goes to Philips here, so I'm wary. Plus I have no way of knowing precisely which model machine they intend to send in either case, so it's not like I can make an informed decision.

What has been the experience of others with this choice? Is there any reason to be wary of defaulting to their auto-CPAP?

[ST Dog]

What has been the experience of others with this choice? Is there any reason to be wary of defaulting to their auto-CPAP?

There is no way to know what you'll get regardless.

They have trouble with prescriptions. Mine was sent in Nov. Then in Feb they claimed to have it then not have it. Finally selected the auto option and replacement arrived within 2 weeks.

Auto machines can be set to fixed modem so no downside for users.

I think it's just easier to send auto machines than manage to get the Rx and program it. It's just a software change for them, so auto machines are easier to deal with.

[HenryBowman]

Thanks for the info. After verifying I had obstructive (not central) apnea, I chose the auto machine this morning. It will be a blessing to get this whole ethnic fire drill over and done with.

[Labromaniac]

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?

[ST Dog]

Does the $50 deal still exist to get them out of my life?

I would assume it does.

Call the phone number for option one in the email (877-907-7508) and tell them you wish to change your choice.


Not that that option has been quick either. Several reported many months between shipping the unit and receiving a check.