Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS, iLab2401NS,
FDA device recall Z-0395-2007 · posted 2007-02-01 · Terminated
Recall details
- Recalling firm
- Boston Scientific Target
- Reason for recall
- The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.
- Action taken
- A customer notification was sent December 1, 2006 indicating the need for the correction.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 24 units
- Distribution
- Nationwide and Portugal.
- Date initiated
- 2006-12-01
- Date posted
- 2007-02-01
- Date terminated
- 2007-12-05
- 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 |