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

[SleeplessinPgh]

Guess it matters what time of day you call!

True.  I hope it's resolved for you quickly.

[ST Dog]

I registered my recalled System One Auto CPAP over a year ago, and a replacement arrived yesterday. It was a refurbished Dreamstation 1 Auto CPAP. 

...
Unfortunately, the System One replacement was *only* the Dreamstation.  There was no power cord, no humidifier, no heated hose, etc. 

Saturday I received a refurbished DS to replace my System One series 60.

I did get a new humidifier, power supply and AC cord. Also a non heated hose. No carry bag, no modem. 

I tried the PRS1 power supply and got the warning. Then tried the new one and same warning. Then unplugged from unit and plugged in again and no warning. Weird. Seemed to be an odd state.

Called number from shipping notice (833-262-1871) at 1:30 CDT today. On hold about 1 minutes before someone pucked up.

Lady claimed the order needed to say heated hose to get one and it didn't. (Luckily it's the same hose, just different color. I had recent bought a white DS hose for the PRS1 as the brown one is unavailable) And they aren't sending bag with refurbs. She made a note to send up the chain, though I doubt it will change anything. 

I did find a bag on eBay for $20 shipped. Looked unused. It doesn't fit in tne PRS1 bag very well.

And I didn't plan to use the modem anyway.

Not perfect, but not terrible.
I'll test it more then put up for when my PRS1 dies.

[Rich66]

Convoluter -- did they know you were only using it for backup?  I have a System One for backup and am just now starting to see about getting a replacement now, but I don't want to say something I shouldn't have said.  I tried the 833 phone number this morning.  The guy that answered said he was trying to pull up the information and then the phone hung up, from their end.

[ST Dog]

Convoluter -- did they know you were only using it for backup?  I have a System One for backup and am just now starting to see about getting a replacement now, but I don't want to say something I shouldn't have said.  I tried the 833 phone number this morning.  The guy that answered said he was trying to pull up the information and then the phone hung up, from their end.

When you register online thee are no questions about how you are using it.

I don't even know if you can register over the phone but I wouldn't even try.

[btreger]

REUTERS


Philips expects to reach recall settlements this year

AMSTERDAM, March 30 (Reuters) - Dutch health technology company Philips (PHG.AS) expects to reach settlements this year relating to its global recall of respiratory devices, CEO Roy Jakobs said in an interview with the Dutch financial daily FD published on Thursday.

"I think we can at least reach a settlement on economic damages this year," Jakobs said without giving details on the expected costs.

Jakobs added he "hopes and expects" also to reach a settlement with the U.S. Food and Drug Administration this year.

A settlement with patients who claim the use of the recalled machines made them sick probably will take longer, he said.

Philips expects to reach recall settlements this year | Reuters

[btreger]

yahoo/news


US FDA identifies recall of Philips' respiratory devices as most serious

(Reuters) - The U.S. Food and Drug Administration (FDA) on Friday classified the recall of Philips' respiratory machines as its most serious type, as their use could cause serious injuries or death.

The Dutch medical devices maker's unit Philips Respironics recalled 1,088 devices in the U.S. on Feb. 10.

Philips was recalling the machines as some devices were assigned incorrect or duplicate serial numbers during initial programming, the U.S. health agency said.

According to the FDA, the recall specifically covers certain DreamStations that Philips also recalled in June 2021.

The duplication could cause therapy to be delivered using the wrong prescription or factory default settings, it added.

US FDA identifies recall of Philips' respiratory devices as most serious (yahoo.com)

[A KLERK]

Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy
This morning in the Netherlands all newspapers published about it: Again Philips recalls another 1233 devices that were already reworked, but mistakes were made doing that.

The official FDA publication is here:
https://www.fda.gov/medical-devices/medi...ay-deliver

For people understanding French, the following Philips website gives deeper insight, videos partly in English:
https://www.philips.fr/healthcare/ressou...pdate/news

[SuperSleeper]

Thanks for the heads-up Arie.

From that notice, it appears that this is a communications issue if one receives therapy changes via a modem (remotely from one's DME or doctor via cloud-based care).

So I would assume that if you have one of the affected machines, just take the removable modem out of the device, and then confirm that the settings are correct on your machine.  If settings aren't correct, then change them to your desired settings after modem removal.  If your device doesn't have a removable modem in the modem slot, you can completely ignore this recall.

From a link in that web page [here]:

Manufacturer Reason for Recall
A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.

[sauerkraut]

What a mess !! I hope the people affected by this chinese fire drill phillips 
calls a recall get some satisfaction !! There must be some real incompetents
running this !! Recalling replacement machines ?? WOW !!
Good Luck to those affected !!
Steve

[btreger]

ADDITIONAL RECALL NEWS

FIERCE

Biotech

Philips' latest ventilator recall linked to inaccurate high-pressure oxygen delivery

Try as Philips might forge a path out of its two-year-long saga of a slew of respiratory device recalls—complete with a new CEO and a new head of the beleaguered connected care division—the company is facing yet another, linked to more than 62,000 of its ventilators.

This time concerns several models of Philips’ Trilogy ventilators: the Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal—none of which have been included in the largest of the Dutch device-maker's recent recalls, where 5.5 million CPAP and BiPAP machines and other devices are being repaired and replaced due to issues with their polyester-based, sound-muffling foam.

Instead, in a letter (PDF) sent to healthcare providers last month, Philips described how these machines might not accurately deliver the amounts of oxygen needed during high-concentration therapies.

62K more Philips ventilators hit with Class I recall (fiercebiotech.com)