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.
- Company
- Boston Scientific Corporation
- Recall Initiated
- May 2, 2008
- Posted
- September 17, 2008
- Terminated
- June 1, 2009
- Recall Number
- Z-2006-2008
- Quantity
- 10 kits
- Firm Location
- Fremont, CA
Reason for Recall
The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.
Distribution
Product was distributed in FL, MI, CA, AZ and SC
Lot / Code Info
Lot Number: 74791
Root Cause
Nonconforming Material/Component
Action Taken
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.
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