Device recall
Z-3161-2011: TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under…
FDA device recall · Class II · TiSport, Llc
Key facts
| Recall number (Z-number) | Z-3161-2011 |
|---|---|
| Recall event | 59305 |
| Product | TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals. |
| Product code | IOR |
| Recalling firm | TiSport, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2012 |
| 510(k) numbers | K990358 |
| FEI number | 3002653226 |
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