iLab Utrasound Imaging System, software controlled Imaging Catheter.
FDA device recall Z-0789-06 · posted 2006-04-22 · Terminated
Recall details
- Recalling firm
- Boston Scientific Target
- Reason for recall
- 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)
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 23 units (13 in the US, 10 outside)
- Distribution
- Product was distributed to 13 US consignees and 10 foreign consignees.
- Date initiated
- 2006-03-06
- Date posted
- 2006-04-22
- Date terminated
- 2007-11-28
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ILAB ULTRASOUND IMAGING SYSTEM (K051679) | Boston Scientific Corp | 2005-07-14 |