iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
- Company
- Boston Scientific Corporation
- Recall Initiated
- April 3, 2014
- Posted
- April 22, 2014
- Terminated
- March 18, 2015
- Recall Number
- Z-1487-2014
- Quantity
- 9 units
- Firm Location
- Fremont, CA
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.
Distribution
USA Nationwide Distribution in the states of NY, NC, DC, FL, PA
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.