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U.S. Department of Health and Human Services

Class 2 Device Recall iLab Ultrasound Imaging System

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  Class 2 Device Recall iLab Ultrasound Imaging System see related information
Date Initiated by Firm April 03, 2014
Date Posted April 22, 2014
Recall Status1 Terminated 3 on March 18, 2015
Recall Number Z-1487-2014
Recall Event ID 67959
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Code Information Model Numbers: H749ILAB120CART0 H749ILAB120INS0 H749ILAB120N2710 Serial numbers: 4219, 4900, 5701, 5827 7516, 7517, 7607 8407, 8434. the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software.  
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
47215 Lakeview Blvd
Fremont CA 94538-6530
For Additional Information Contact Brent Hathcock
763-494-1133
Manufacturer Reason
for Recall		 Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Boston Scientific sent an Urgent Medical Device Field Correction letter to all affected customers via hand delivery by BSC sales representatives. The letter identifed the affected product, problem and actions to be taken. Customers were asked to immediately post the Field Correction information in a visible location near the system(s) to ensure it is easily accessible to all users of the device. For question contact your local Sales Representative.
Quantity in Commerce 9 units
Distribution USA Nationwide Distribution in the states of NY, NC, DC, FL, PA
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.
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