FDA Medical Device Recalls (openFDA)
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 number
- Z-2006-2008
- Recalling firm
- Boston Scientific Corporation
- 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.
- Status
- Terminated
- Initiated
- 2008-05-02
- Posted
- 2008-09-17
- Terminated
- 2009-06-01
- 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
- Lot, serial or model codes
- Lot Number: 74791
- 510(k) numbers
- ["K063493"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2939204
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28