(Another) recall for Philips - This Time Dreamwear Masks

[Gator5000e]

It's not been a good year or two for Philips. Although this recall doesn't really concern me as I have nothing the magnets would cause an issue with. Here is the beginning of the release - link to the full release is below. Sorry if this has been posted already. I did not see anything.

The U.S. Food and Drug Administration (FDA) is alerting health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have magnets (placements shown by black circles in the picture below) and can cause potential injuries or death when use of a recalled mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body.

These potential adverse events can occur in people who use the masks, or in people near a person using the mask. Additionally, the recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.

https://www.fda.gov/medical-devices/let ... may-affect

[D.H.]

Wow!

I don't see how Philips can remain in this business long-term! At the moment, there's a shortage of machines, so DS2's and refurbished DS1's can still be sold. Also, machines will be replaced less frequently due to the shortage, so more supplies can still be sold. However, this can only keep them in business short-term.

Despite my lack of confidence, I accepted a DS2 due to the shortage.

One caveat here. I never had an issue with the DS1 (odor, particles, or symptoms), I used an old machine (an F&P HC-231) until the DS2 showed up.

[mummmz]

It's not only Phillips that uses magnets in their masks. My ResMed F30 uses magnets too. I don't have a pacemaker or the other devices mentioned. I have a few tooth fillings and a titanium knee replacement. I don't think the fillings are impacted and I'll make sure not to use the mask on my knee so I think I'm good. I like the magnet clasp. Is titanium magnetic? I hadn't thought of implanted lens for cataracts but it says they are not impacted. Here's the FDA link:
https://www.fda.gov/medical-devices/saf ... may-affect

[jdm5]

The new Bleep Eclipse will use magnets too I understand.

Wonder if they would be affected

[Pugsy]

The new Bleep Eclipse will use magnets too I understand.

Wonder if they would be affected

Anything that has magnets has the potential to be a problem with people who may have some sort of device implanted.
The Eclipse comes with a "warning" as to this but a lot will depend on where the implant might be, what sort of implant and the distance between that implant and any magnets.

I have a device implanted that sends impulses to my spine. It is implanted down near my right iliac crest...a long way from my Eclipse mask and the magnets. I had the device implanted in Feb of this year. I have used the Eclipse since that time without any issues.

Now if someone had some sort of device implanted up in the neck area or upper chest....might be a different story.

[Gator5000e]

I will continue to use them until they don't make them (if that happens). When I first saw the recall sent from Amazon (where I buy the masks), I figured holy ****, the material is degrading or something. But when I saw it was the magnets, I said really? I guess if you have some type of pacemaker or implanted device susceptible to magnets it might be an issue. But shouldn't it be a stronger warning than a recall?

[ChicagoGranny]

Please keep this in perspective. All patients who have implanted devices that are affected by magnetism are carefully warned of the dangers by their medical team.

[SleepGeek]

Please keep this in perspective. All patients who have implanted devices that are affected by magnetism are carefully warned of the dangers by their medical team.

Have to agree. Anyone who had any device implanted would have been advised about magnets and microwaves. So I don't understand the idea behind a *Recall*. Something sounds amiss as a *Recall* won't fix their problem.

[reader2580]

This sucks as I can't tolerate a normal full face mask. I assume there is a stop sale on the replacement cushions. I wonder if Philips might just discontinue this mask?

[ChicagoGranny]

From the FDA notice in the OP:

You may continue using the mask, if you or someone near you when using the recalled mask, do not have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.

[Janknitz]

The Dreamwear is one of the masks implicated. Where's the magnet???

[reader2580]

From the FDA notice in the OP:

You may continue using the mask, if you or someone near you when using the recalled mask, do not have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.

I don't know if this was aimed at me or not. Yes, I understand I can continue to use my mask. My concern is eventually the mask cushion will tear and start to leak as this happens for me every few months. Presumably the cushions will no longer be available for sale. The recall says nothing about if Philips is going to replace masks or reimburse users for the cost of the mask. Even if Philips redesigns the mask it probably won't be out for months while it gets designed, certified, and manufactured.

[reader2580]

The Dreamwear is one of the masks implicated. Where's the magnet???

I use the Dreamwear full face mask and the magnets are in the clips at the end of the headgear.

[Pugsy]

The Dreamwear is one of the masks implicated. Where's the magnet???

On the headgear of the full face mask next to the corners of the mouth area.
https://www.cpap.com/productpage/pr-dre ... k-headgear

The under the nose cushion or pillows DreamWear doesn't seem to have any magnets near as I can tell.

[weroberts75]

So this thread got my attention, because like many I'm waiting for the Eclipse and interested in the future of magnet technology for CPAP.
I did find Philip's timing of this recall interesting, since we've heard that the Eclipse will most likely come in October.

After doing a little digging online, no one is stopping the use of magnets in CPAP masks.
Philips will continue distributing these masks, but with more warning to consumers about the dangers of such masks.
The recall is entirely voluntary for those affected due to metal implants, pacemakers or defibrillators, etc.
The report I found said that there have been 14 serious injuries but 0 deaths as a result of the recalled CPAP masks with magnets.

A good review of the recall can be found here:

https://sleepreviewmag.com/sleep-treatm ... l-magnets/