Device recall
Z-0532-2014: Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB…
FDA device recall · Class II · Trans American Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0532-2014 |
|---|---|
| Recall event | 66064 |
| Product | Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number |
| Product code | IZL |
| Recalling firm | Trans American Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 29, 2015 |
| 510(k) numbers | K092713 |
| FEI number | 1000219700 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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