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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