Recall Z-2006-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Boston Scientific Corporation
iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number: 1801; Product is manufactured and distributed by Boston Scientific Corporation, Fremont, CA The iReview" Software is provided on CD and is a computer application designed for reviewing cases recorded with firm's iLab "System, and for exporting stills or videos of those runs.
| Date | Sep 17, 2008 (initiated May 2, 2008) |
| Status | Terminated |
| Reason | The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format. |
| Root cause | Nonconforming Material/Component |
| Action | Customer notifications sent on May 2, 2008 indicating the need for field correction and included a replacement version of the software kit. For customer assistance, contact Boston Scientific at 1-508-652-5594. |
| Quantity | 10 kits |
| Distribution | Product was distributed in FL, MI, CA, AZ and SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063493 | I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 Boston Scientific Corp, Dec 21, 2006 |