Device recall
Z-0164-2007: 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.
FDA device recall · Class II · USA Instruments Incorporated
Key facts
| Recall number (Z-number) | Z-0164-2007 |
|---|---|
| Recall event | 36612 |
| Product | 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System. |
| Product code | MOS |
| Recalling firm | USA Instruments Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2012 |
| 510(k) numbers | K052916 |
| FEI number | 3005214683 |
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