ResMed recalls AirFit N10 Nasal Masks with potential magnetic interference for patients using medical implants. Affected units include specific model lots from 2020-07 onward. Contact ResMed for details.
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
ResMed is recalling AirFit N10 Nasal Masks that could interfere with medical implants due to magnets. This risk is serious for people with certain implants or metal objects, as the masks might cause harm if used too close.
The masks contain magnets that could interact with active medical implants or metallic objects. This might cause the implant to malfunction or move, potentially leading to injury if the mask is used too close to the implant.
People using AirFit N10 Nasal Masks with medical implants or metallic objects containing ferromagnetic material are at risk. Those with pacemakers, neurostimulators, or other magnet-sensitive devices are most vulnerable.
Check for AirFit N10 Nasal Masks with User Guide 628153/version 2020-07 or earlier. The product has specific UDI-DI/GTIN numbers listed in the recall notice.
Look for the User Guide version number and UDI-DI/GTIN codes listed in the recall notice to confirm if your mask is affected.
Reach out to ResMed directly for guidance on next steps if you have an affected mask.
The recall does not require immediate stop use; however, people with medical implants should take precautions to avoid close contact with the mask.
If you have a pacemaker or other magnet-sensitive implant, you should avoid using the mask until you confirm it's safe with ResMed.
Check the User Guide version number and UDI-DI/GTIN codes listed in the recall notice to see if your mask is included.
We’ve drafted a message you can send ResMed to request your refund or repair — edit it as you like.
Subject: Recall Z-0536-2024 — ResMed ResMed Hello, I own a ResMed that is covered by recall Z-0536-2024 from ResMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
