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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific iLab

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  Class 2 Device Recall Boston Scientific iLab see related information
Date Initiated by Firm December 01, 2006
Date Posted February 01, 2007
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-0395-2007
Recall Event ID 37126
510(K)Number K051679  
Product Classification ultrasound - 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 CA 94538
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.
FDA Determined
Cause 2		 Other
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 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 = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.
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