Recall Z-0536-2024 ยท BZD Ventilator, Non-Continuous (Respirator)
ResMed Ltd.
AirFit N10 Nasal Masks and User Guide
| Date | Dec 21, 2023 (initiated Nov 20, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Device Design |
| Action | On 11/20/23, "Urgent Field Safety Notices" and FAQs were placed on the firms website at www.resmed.com/magnetupdate, and these notices were emailed to healthcare providers, and distributors who were asked to do the following: 1) Provide a copy of this notice and the physician letter to prescribing physicians, and/or any other relevant healthcare professionals, notifying them of the updated labeling (contraindications and warning). 2) Provide a copy of the patient letter to all patients currently using an affected mask with magnets, notifying them of the updated labeling (contraindications and |
| Quantity | 199,796 |
| Distribution | US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132887 | AIRFIT N10 Resmed, Ltd., Dec 20, 2013 |