ResMed Ltd.: AirFit F30i Full Face Mask and User Guide

Recall number

Z-0542-2024

Recalling firm

ResMed Ltd.

Product

AirFit F30i Full Face Mask and User Guide

Status

Open, Classified

Initiated

2023-11-20

Posted

2023-12-21

Terminated

not on file

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 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.

Quantity

2,037,323

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, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA

Lot, serial or model codes

All mask lots used with User Guide 638225/version 2020-02, and prior. UDI-DI/GTIN: 619498633326, 619498633067, 619498633012, 619498633340, 619498633302, 619498633333, 619498633050, 619498633319, 619498633005, 619498633135, 619498633128, 619498633364, 619498633388, 619498633371, 619498633401, 619498633395, 619498633104, 619498633142, 619498633111, 619498633081, 619498633074

510(k) numbers

["K183512"]

PMA numbers

not on file

Product code

BZD

Firm FEI

3004604967

Firm city

Bella Vista

Firm state

not on file

Firm country

Australia

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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