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.
FDA Recall Z-2006-2008 · Posted 2008-09-17
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeIYN
Date Initiated2008-05-02
Date Terminated2009-06-01
Product Quantity10 kits
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Product was distributed in FL, MI, CA, AZ and SC
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.