Recalls / —
—#70852
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.
- FDA product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K063493
- Affected lot / code info
- Lot Number: 74791
Why it was recalled
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 (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 47900 Bayside Pkwy, Fremont, California 94538-6515
Distribution
- Distribution pattern
- Product was distributed in FL, MI, CA, AZ and SC
Timeline
- Recall initiated
- 2008-05-02
- Posted by FDA
- 2008-09-17
- Terminated
- 2009-06-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #70852. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.