Drug recall
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and…
FDA recall event 89062 · Class II · Invacare Corporation
Key facts
| Event ID | 89062 |
|---|---|
| Recall numbers | Z-0445-2022, Z-0446-2022, Z-0447-2022 |
| Recalling firm | Invacare Corporation |
| Product type | Devices |
| Products | 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, Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP, Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Nov 12, 2021 |
| Report date | Jan 12, 2022 |
| City | Elyria |
| State | OH |
| Country | United States |
| FEI number | 1525712 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: