AirFit N20 Nasal Mask and User Guide
FDA device recall Z-0539-2024 · posted 2023-12-21 · Open, Classified
Recall details
- Recalling firm
- ResMed Ltd.
- Reason for recall
- 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
- Action taken
- 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 warning). Note, patients are instructed in the patient letter to contact their mask provider for a replacement mask if they are now contraindicated. 3) Provide a replacement mask for contraindicated patients to an alternative mask without magnets in a timely manner. Where an alternative mask is not available, inform patients to consult with their physician. 4) Instruct patients to consult their physician and/or manufacturer of their implant / other medical device if they require additional information on the potential adverse effects of magnetic fields for their particular device (as described in warnings). 5) For alternative mask options, please contact your ResMed or Customer Service representative. 6) Complete and return the customer acknowledgement form via email to magnetresponse@resmed.com For any questions, please contact your local ResMed contact or visit www.resmed.com/contact.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- BZD
- Quantity affected
- 7,724,968
- 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,
- Date initiated
- 2023-11-20
- Date posted
- 2023-12-21
- Location
- Bella Vista, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AirFit N20 (K171212) | Resmed, Ltd. | 2017-09-28 |