Airtouch and Airfit ResMed Masks
Brand(s)
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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