Resmed requested the mask be returned so that an engineering investigation can be performed.In response to the request, resmed was informed the mask is not available to be returned to resmed for evaluation.On november 20, 2023, a field safety notice was issued by resmed (mwm-2023-fsn-01) for all lots of resmed masks with magnets: airfit n10, airfit n10 for her, airfit n20, airfit n20 for her, airtouch n20, airtouch n20 for her, airfit f20, airfit f20 for her, airfit f20 nv, airtouch f20, airtouch f20 for her, airfit f30, airfit f30i.Resmed has updated the contraindications and warnings in our mask with magnets¿ user guides so clinicians and patients aware of the potential risks associated with the magnetic fields and to take precautionary measures when using the mask.Corrective and preventative actions are being taken by resmed to resolve the issue.Mcapa-1637 resmed reference#: (b)(4).
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