Health product recall

Airtouch and Airfit ResMed Masks

Last updated

Summary

Product
Airtouch and Airfit ResMed Masks
Issue
Medical devices - Device compatibility
What to do

Instructions provided on how to reduce chances of interference by magnets in mask. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Airtouch N20 Contact manufacturer 63903 63900 63901 63902 63904 63906 63905 63907
Airtouch F20 Contact manufacturer 63002 63004 63006 63018 63007 63014 63017 63008 63003 63005 63013 63000 63009 63012 63015 63001 63016
Airfit F30 Starter Pack Contact manufacturer 64140
Airfit F30 Multi Contact manufacturer 64141 64142
Airfit N10 For Her Sys Contact manufacturer 63204 63201 63207
Airfit N10 Sml Sys Contact manufacturer 63289 63228 63229
Airfit F30 Sys - Amer Contact manufacturer 64100 64101
Airfit N10 Std Sys Contact manufacturer 63203 63200 63206
Airfit F20 Contact manufacturer 63400 63403 63448 63404 63453 63451 63454 63456 63447 63452 63445 63446 63450 63455 63401 63402 63449
Airfit N20 Contact manufacturer 63505 63538 63500 63539 63502 63507 63504 63536 63537 63534 63535 63501 63503 63506
Airfit F30 Sys - Slm Contact manufacturer 64105 64104
Airfit F30i Contact manufacturer 63306 63330 63331 63334 63332 63305 63333 63301 63300
Airfit N10 Wide Sys Contact manufacturer 63202 63205 63208

Issue

Under certain circumstances when a magnet in a Resmed mask(s) is in close proximity to certain medical implants/devices, potential magnetic interference could affect the performance or implanted position of the medical implant/device which has the potential to lead to serious injury or death.

Recall start date: November 20, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Resmed Pty Limited
1 Elizabeth Macarthur Drive, Bella Vista, New South Wales, Australia, 2153
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74733

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