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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific iReview Software

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 Class 2 Recall
Boston Scientific iReview Software
see related information
Date Posted September 17, 2008
Recall Status1 Terminated on June 01, 2009
Recall Number Z-2006-2008
Recall Event ID 48122
Premarket Notification
510(K) Number
K063493 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
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.
Code Information Lot Number: 74791
Recalling Firm/
Manufacturer
Boston Scientific Corporation
47900 Bayside Pkwy
Fremont, California 94538-6515
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = BOSTON SCIENTIFIC CORP.
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