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

[btreger]

I am not quite sure what you mean when you said "There is no replacement DS Go machine....".  The replacement machines I assume are the DS Go machines Philips has received back from the recall program and have fixed the foam problem (ie; refurbished), and then send out to another consumer, who then in turn returns their faulty recall machine and on and on goes the cycle.  

OK: Let me try one more time, there is no new or refurbished GO Machine from Philips...
They have made an offer for those owners who registered their machines during the recall:
They will send you an e-mail that provides 2 options, for the return of your registered device:

1. Receive a refurbished DS1 device
2. Receive a check for up to $500
Your DME has nothing to do with any of this.
If you are still having a problem I would suggest you contact Health Canada

[chasmm]

They have made an offer for those owners who registered their machines during the recall:
They will send you an e-mail that provides 2 options, for the return of your registered device:

1. Receive a refurbished DS1 device
2. Receive a check for up to $500

This isn't entirely correct. I am a Dreamstation Go user with a registered machine. Philips offered the following choices (for me, copied directly from the recall site, bolding is mine):

OPTION 1 - Financial payment for return of affected units: You can select the financial payment option below to receive $500, based on manufacturing date of your affected device. You will receive this payment via check when we receive your affected DreamStation Go device. Philips Respironics will cover the packaging and return costs once you have taken your device to a FedEx location. Please note return instructions will be included in the Patient Portal once you select this option.
OPTION 2 - Elect to receive a replacement DreamStation Go device If you elect to remain in the remediation pathway, you must make the selection "Receive a device" below.

That said, I haven't heard of anyone from this site or other social media, other than in Australia, receiving a remediated Go yet. I don't profess to know what EVERYONE has posted on social media...

It's certainly possible that remediated Dreamstation Go devices are starting to trickle out from Philips.

[btreger]

E-Mails from Philips

04/19/2023

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

07/05/2023

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.

You must select one of the following two options below in the Patient Portal. There is no default option, and no action can be taken in the absence of your selection. If you have retained a lawyer, you may wish to consult with them before making your decisions.

Please sign into the Patient Portal to select your preferred option:

OPTION 1 - Financial payment for 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. The payment we offer is to help ensure that affected units are no longer in use. You will receive this payment via check when we receive your affected DreamStation Go device. Philips Respironics will cover the packaging and return costs once you have taken your device to a FedEx location. Please note return instructions will be included in the Patient Portal once you select this option.


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.

Philips never offered any additional updates between these two dates.

[Tampa Jim]

October 10, 2023 @ 3:04pm

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. You have also taken
the necessary step to select between financial payment for affected units or to receive a replacement device.
Our records show that you have elected to receive a replacement device.
Unfortunately, we are experiencing unexpected delays in shipping replacement DreamStation Go replacement
devices. At this time, we do not have an estimated time in which these replacement devices will be able to ship
but are working towards a resolution.
We will continue to update you on the status of the shipping delay. If you have any questions, please call 1-833-
262-1871.
Thank you for your continued patience and trust.

[btreger]

October 10, 2023 @ 3:04pm
We will continue to update you on the status of the shipping delay. If you have any questions, please call 1-833-
262-1871.
Thank you for your continued patience and trust.

I don't know if you called this number, but I did. I was told that Philps was not refurbishing Go machines or sending any out. Call and check yourself.

[cate1898]

Thank you Tampa Jim for the Philips contact phone number, much better than the other number I had. I actually got someone to answer my call quite promptly. After obtaining both my old (2019) DS Go's serial number and the DS Go replacement device's serial number, she with the assistance of her manager were able to find out that my replacement DS Go was manufactured in Jan. 2021, never sold to anyone, and found that the remediation was indeed done on this replacement device.

So I guess we can now add Canada to the list along with Australia of countries we know where people are receiving remediated devices.

Also of note, she confirmed that when Philips remediates devices, they do not put anything on them to indicate remediation has been completed.

[Tampa Jim]

I guess we can now add Canada to the list along with Australia of countries we know where people are receiving remediated devices.

My guess ... the US will come after CDN and AUS since our FDA has been much more relaxed with them. I'm priority listed and it doesn't seem to matter a bit. My DS1 replacement took 1.5 years, even with the priority list boost. My wife's DS1 replacement, registered at the same time, took much longer. And my DS1 was replaced with a new DS2, she received a DS1 refurbished unit instead. Obviously, Philips will do things at their own pace. We have no influence.

[chasmm]

E-Mails from Philips

04/19/2023

.............
07/05/2023

...............

Philips never offered any additional updates between these two dates.

The info I posted was on the Philips recall site on 09/02/2023. I intentionally waited after they announced the "cash for Go" to see if there would be any more info about potential Go machines...either new or remediated.

[btreger]

FIERCE

Biotech

Philips recalls a handful of hospital ventilators equipped with substandard power circuits

Once again, Philips has been hit with an FDA Class I label to correct certain respiratory support devices.

The latest recall—a voluntary product correction, rather than a full-blown product removal, per an FDA notice Friday—concerns just a few of Philips’ V60 and V60 Plus ventilators. It marks the fifth Class I tag that the Dutch device-makers Respironics division has received this year alone, all of which have rolled in as the company still works its way through repairing and replacing all 5.5 million CPAP and BiPAP machines, ventilators, and other devices affected by the still-ongoing June 2021 recall.


Philips recalls V60 ventilators equipped with substandard part (fiercebiotech.com)

[btreger]

HME News


PHILIPS REPORTS SALES GROWTH FOR Q3

AMSTERDAM – Philips’ Connected Care business saw a 10% increase in comparable sales in the third quarter, with double-digit growth in monitoring. 

Overall, the company reported group sales of EUR 4.5 billion and comparable sales growth of 11%. 

Completing the Philips Respironics recall remains the company’s “highest priority,” with the remediation of the sleep therapy devices almost complete and the remediation of the ventilators ongoing, said Jakobs.

Earlier this month, however, the U.S. Food and Drug Administration requested that Philips conduct additional testing on the health risks related to the sound abatement foam in certain recalled ventilators and BiPAP and CPAP devices.

Philips reports sales growth for Q3 | HME News