Device recall
Z-0849-04: Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by…
FDA device recall · Class II · USA Instruments Inc.
Key facts
| Recall number (Z-number) | Z-0849-04 |
|---|---|
| Recall event | 28693 |
| Product | Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medical Solutions. |
| Product code | LNH |
| Recalling firm | USA Instruments Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 1, 2012 |
| 510(k) numbers | K030371 |
| FEI number | 3005214683 |
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