Device recall
Z-0395-2007: Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use…
FDA device recall · Class II · Boston Scientific Target
Key facts
| Recall number (Z-number) | Z-0395-2007 |
|---|---|
| Recall event | 37126 |
| Product | Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS, iLab2401NS, Distributed by and Manufactured by: Boston Scientific Corporation IVUS, Technology Center, 47201 lakeview Parkway, Fremont, CA 94538 |
| Product code | DQO |
| Recalling firm | Boston Scientific Target |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2007 |
| 510(k) numbers | K051679 |
| FEI number | 2939204 |
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