• 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 iLab

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


New Search Back to Search Results
 Class 2 Recall
Boston Scientific iLab
see related information
Date Posted February 01, 2007
Recall Status1 Terminated on December 05, 2007
Recall Number Z-0395-2007
Recall Event ID 37126
Premarket Notification
510(K) Number
K051679 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Boston Scientific brand iLab® Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS, iLab2401NS, Distributed by and Manufactured by: Boston Scientific Corporation IVUS, Technology Center, 47201 lakeview Parkway, Fremont, CA 94538
Code Information All serial numbers.
Recalling Firm/
Manufacturer
Boston Scientific Target
47900 Bayside Parkway
Fremont, California 94538
Consumer Instructions Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.
For Additional Information Contact Tara Lopez
510-440-7874
Manufacturer Reason
for Recall
The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.
Action A customer notification was sent December 1, 2006 indicating the need for the correction.
Quantity in Commerce 24 units
Distribution Nationwide and Portugal.
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
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.
-
-