Class 2 Device Recall Boston Scientific iLab

• Date Initiated by Firm: December 01, 2006
• Date Posted: February 01, 2007
• Recall Status: Terminated 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.
• FEI Number: 2939204
• 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: 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