Device recall
Z-1263-2007: Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil…
FDA device recall · Class II · Hitachi Medical Systems America Inc
Key facts
| Recall number (Z-number) | Z-1263-2007 |
|---|---|
| Recall event | 44702 |
| Product | Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the cable is referred to as the balun assembly or balun trap. The shoulder coil… |
| Product code | LNH |
| Recalling firm | Hitachi Medical Systems America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2010 |
| 510(k) numbers | K002420 |
| FEI number | 1528028 |
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