Recall Z-0789-06 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Target
iLab Utrasound Imaging System, software controlled Imaging Catheter.
| Date | Apr 22, 2006 (initiated Mar 6, 2006) |
| Status | Terminated |
| Reason | Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only) |
| Root cause | Other |
| Action | The firm initiated recall actions on March 6, 2006. On March 21, 2006, the firm issued notification letters to all appropriate personnel at hospitals and user facilities to inform them of actions taken by Boston Scientific to remediate any risks. |
| Quantity | 23 units (13 in the US, 10 outside) |
| Distribution | Product was distributed to 13 US consignees and 10 foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051679 | ILAB ULTRASOUND IMAGING SYSTEM Boston Scientific Corp, Jul 14, 2005 |