On March 1, 2024 Sleepnet Corporation issued a voluntarily recall on masks with magnets which are intended to be used with positive airway pressure devices such as CPAP or bi-level: Mojo Full Face Vented Mask, Mojo Full Face Non Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non Vented Mask, Mojo 2 Full Face AAV Non Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask.

This recall is being initiated based on information obtained from post market surveillance indicating a possible risk to patients and anyone in close physical contact with the mask, having an active medical implant or metallic implant that can be impacted by the magnetic field. The existing contraindications and warnings are being revised as a proactive measure to provide additional safety information to patients and healthcare professionals. To date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets.

When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the position of the implant. This could potentially lead to serious injury or death. Sleepnet Corporation has been distributing masks with magnets since 2006 and has not received any reports of injury or potential injury relating to the magnets.

The images below show the affected masks and location of the magnets. The location of the magnets on the mask and on the headgear clips are circled.

•  Phantom 2 Nasal Mask – part numbers 50182
• iQ 2 Nasal Mask-  part number 50169

1. If you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets, stop using the mask.

2. Contact your mask provider for a replacement mask that does not contain magnets.

3. If you or anyone (example: household members, bed partners, caregivers, etc.) in close

physical contact with your mask does NOT have an active medical implant or metallic implant

that will interact with magnets, you do not need to do anything.

4. If you are unsure whether or not you should use your mask with magnets, consult your

physician or the manufacturer of your implant.

The existing contraindications and warnings are being revised as a proactive measure to provide additional safety information to patients and healthcare professionals.

Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher, etc. If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.

Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx.16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.

What to Do:

• Keep the magnets at a safe distance of six inches (150 mm) away from implants or medical devices that could be affected by magnetic interference.
• Patients should reach out to their physician or the manufacturer of their implant or other medical device for further details regarding possible negative effects of magnetic fields on their device.
• Visit the ResMed Magnet Update website for detailed information about the recent updates made to contraindications and warning labels.

Contact Information:

Customers in the U.S. with questions about this recall should contact SleepNet Corporation at call 1-800-742-3646.