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
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For Additional Information Contact |
Brent Hathcock 763-494-1133
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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
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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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