Recall Z-0537-2024— ResMed Ltd.
Class I · Ongoing
Class I FDA medical device recall by ResMed Ltd., initiated 2023-11-20. It names one FDA 510(k) clearance: K170924. Product: AirFit F20 Full Face Mask and User Guide. 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.
- Recalling firm
- ResMed Ltd.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-11-20
- Firm location
- Bella Vista, N/A, Australia
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AirFit F20 Full Face Mask and User Guide
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.