Date Initiated by Firm |
May 02, 2008 |
Date Posted |
September 17, 2008 |
Recall Status1 |
Terminated 3 on June 01, 2009 |
Recall Number |
Z-2006-2008 |
Recall Event ID |
48122 |
510(K)Number |
K063493
|
Product Classification |
Software - 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 CA 94538-6515
|
For Additional Information Contact |
508-652-5594
|
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 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = IYN and Original Applicant = BOSTON SCIENTIFIC CORP.
|