Recall Z-1487-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Boston Scientific Corporation
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
| Date | Apr 22, 2014 (initiated Apr 3, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 9 units |
| Distribution | USA Nationwide Distribution in the states of NY, NC, DC, FL, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.