Device recall
Z-2001-2012: superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for…
FDA device recall · Class II · superDimension, Inc
Key facts
| Recall number (Z-number) | Z-2001-2012 |
|---|---|
| Recall event | 62381 |
| Product | superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a… |
| Product code | OGK |
| Recalling firm | superDimension, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2013 |
| 510(k) numbers | K052260 |
| FEI number | 3004962788 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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