Philips Respironics has issued an Urgent Medical Device Correction on a handful of their Nasal and Full-Face CPAP Masks. All of these CPAP masks have magnets on the headgear straps. These magnets are designed to help you attach and detach your headgear more easily. However, they can cause issues for certain CPAP users. Let’s dive into the details of what this might mean for you below. You can read through the formal notification on the Philips website by clicking here
. Click on any of the words in blue to see details on the items in blue.
What Implants and Devices are affected by these CPAP Mask Magnets?
Use of the mask is contraindicated for patients and their household members, caregivers, and bed
partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by
magnets, including but not limited to:
- Implantable cardioverter defibrillators (ICD)
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e. neck and head)
- CSF (cerebral spinal fluid) shunts (e.g., VP (ventriculo peritoneal) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone
- conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., insulin pumps)
- Hypoglossal Nerve Stimulators
- Devices labeled as MR (magnetic resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
Which Philips Respironics Masks are affected?
There are 4 CPAP mask models that we have sold that are affected. They are the Amara View Full Face
, DreamWear Full Face
, DreamWisp Nasal
, and the Wisp Nasal
CPAP mask. All of these models feature magnets on the headgear straps that can be an issue for affected CPAP users. For most of these models there is not resolution, and you would need to change mask models. For one however, there is a quick and easy resolutions. Below we go over the individual affected masks and appropriate models that would be similar if you need to make a change.
What do I do if I am affected by the Magnets on the CPAP mask?
All 4 of these masks affected by the Urgent Medical Device Correction
have either a comparable alternative that we can recommend or might even be able to be resolved with a quick alternative clip. Let’s look at each of the masks individually to see what might be best for you.
The DreamWear full face is a Minimal contact full face CPAP mask. It features magnetic clips that are built into the cushion of the mask. For this mask there is no resolution that will allow you to continue use of the DreamWear Full. This means that you would need to seek out an alternative. Unfortunately, the only direct competitor to this mask would be the F30i from ResMed
, but it also has magnets. So, your best bet would most likely be the Evora Full Face by fisher and paykel
. It has a similar fit with a fairly low profile, but it does have a front tube attachment.
For the Amara View there is a pretty nice and easy way to continue use of this mask without magnets. The only thing necessary is to purchase the older style manual clips for the Amara View. These clips allow you to manually clip the headgear into place without the magnets being attached at all. To view these manual clips, click here
. If you would like to change models entirely, then the Evora Full Face
would again be your best bet.
The DreamWisp is a tough one to resolve. This is because it is the only Nasal CPAP mask that has an over the head tube connection. Because of that you will have to sacrifice something in the change. You can convert to a standard Nasal CPAP mask without magnets like the Eson 2
or Mirage Fx
. This allows you to keep the standard “over-the-nose” nasal fit. If you would like to keep the top-of-head tube connection you would move to a nasal cradle design like the Evora Nasal
, DreamWear Nasal
or the N30i
The Wisp Nasal Mask is another tough one to replace. That is because the headgear and frame are pretty unique. There is no frame in front of the nose which gives you a nice clear line of sight while wearing the Wisp. Masks like N20 and the N10 which would be very similar to the Wisp also have magnets. So, in this case again you would have to go to a more standard style Nasal Mask
with a traditional frame like the Eson 2
or Mirage FX
to achieve the traditional nasal fit. You can also consider a Nasal Pillow mask
or Nasal Cradle mask
to achieve the open line of sight.
What does ResMed say about their Mask Magnets?
I reached out to my representative at ResMed to see where they stand on the Mask Magnet issue. Since ResMed has quite a few CPAP masks that feature really nice magnets, I was concerned. Please keep in mind that this is the response on the day that this blog was written. If this response changes, then I will do my best to update this information. I will also clarify that despite the word “recall” below, I have not heard the word “recall” from Philips or anyone else so far.
“We are aware of the September 6, 2022, recall of certain Philips masks due to a safety issue with magnets that may affect some medical devices in or on a patient. ResMed is carefully reviewing the issues outlined in the FDA’s recall report, as we do with any relevant regulatory activity in the market. We believe our (ResMed) masks are safe to use. While some ResMed masks use magnets in the lower headgear straps and the frame to assist with ease of closure and a secure fit, these masks contain magnets designed to a strength below the guidance from the International Commission of Non-Ionizing Radiation Protection (ICNIRP) for use of magnets in this setting, and ResMed masks provide instructions to users about the use of magnets in proximity to other medical devices. We will consider whether additional work is needed to further demonstrate the continuing safety of our masks that use magnets. ResMed continually evaluates our products against applicable regulatory standards, industry guidance, safety standards, and good clinical practice, as they develop.”