Device recall
Z-2240-2010: PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low…
FDA device recall · Class II · Odin Medical Technologies Ltd.
Key facts
| Recall number (Z-number) | Z-2240-2010 |
|---|---|
| Recall event | 56258 |
| Product | PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI device used to gather cranial images. |
| Product code | LNH |
| Recalling firm | Odin Medical Technologies Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2010 |
| 510(k) numbers | K032541 |
| FEI number | 3003348378 |
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