Device recall
Z-0445-2022: Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model…
FDA device recall · Class II · Invacare Corporation
Key facts
| Recall number (Z-number) | Z-0445-2022 |
|---|---|
| Recall event | 89062 |
| Product | 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, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG |
| Product code | ITI |
| Recalling firm | Invacare Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170507 |
| FEI number | 1525712 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database