Recall Z-0395-2007 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Target
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
| Date | Feb 1, 2007 (initiated Dec 1, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | A customer notification was sent December 1, 2006 indicating the need for the correction. |
| Quantity | 24 units |
| Distribution | Nationwide and Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051679 | ILAB ULTRASOUND IMAGING SYSTEM Boston Scientific Corp, Jul 14, 2005 |