Z-2006-2008

iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number...

Name: Z-2006-2008 iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number...
Creator: Boston Scientific Corporation
Published: 2008-05-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-05-02 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number: 1801; Product is manufactured and distributed by... on 2008-05-02. The reason FDA records is "The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2006-2008
Status: Terminated
Initiated: 2008-05-02
Posted: 2008-09-17
Terminated: 2009-06-01
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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 10 kits
Distribution: Product was distributed in FL, MI, CA, AZ and SC
Product codes and lots: Lot Number: 74791

Product code IYN

K063493Class III Review Software(accessory to) Ilab Ultrasound Imaging System) Version1.0Boston Scientific Corp / cleared 2006-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)