Recall Z-0446-2022 ยท ITI Wheelchair, Powered
Invacare Corporation
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C
| Date | Nov 12, 2021 |
| Status | Open, Classified |
| Reason | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury |
| Root cause | Software design |
| Action | Invacare issued Urgent Medical Device Letter issued on 11/12/21 to consignees who received devices with LiNX Gyro modules containing firmware version 6.1.2. This letter also contains instructions for consignees who upgraded devices in the field to version 6.1.2. A Consumer Letter will be provided on the recall website for Providers to send to end users who are impacted. Letter states reason for recall, health risk and action to take: Visit www. Invacare.com/RC916 within five (5) business days of receiving this notice. Enter the requested identification information to access the list of power |
| Quantity | 303 units US; 20 units OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP Invacare Corporation, Jan 2, 2020 |