medical Class I Updated 2023-12-27

ResMed Ltd. recalls AirTouch F20 Full Face Mask and User Guide

Recalled Product

AirTouch F20 Full Face Mask and User Guide

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All mask lots used with User Guide 638220/version 2020-02, and prior. UDI-DI/GTIN: 619498630028, 619498630189, 619498630172, 619498630141, 619498630059, 619498630097, 619498630080, 619498630011, 619498630004, 619498630042, 619498630066, 619498630134, 619498630073, 619498630035, 619498630158, 619498630165, 619498630523, 619498630530, 619498630516, 619498630363, 619498630356, 619498630349, 619498630387, 619498630370
View official government recall

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