Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific iReview Software

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Boston Scientific iReview Softwaresee related information
Date Initiated by FirmMay 02, 2008
Date PostedSeptember 17, 2008
Recall Status1 Terminated 3 on June 01, 2009
Recall NumberZ-2006-2008
Recall Event ID 48122
510(K)NumberK063493 
Product Classification Software - Product Code IYN
ProductiReview" 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
FEI Number 2939204
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
ActionCustomer 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 Commerce10 kits
DistributionProduct was distributed in FL, MI, CA, AZ and SC
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYN
-
-