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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Lot Number: 74791
Products Sold
Lot Number: 74791
Boston Scientific Corporation is recalling iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalo due to The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, IN, MI, SC
Page updated: Jan 10, 2026