iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular patho

FDA device recall Z-1487-2014 · posted 2014-04-22 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IYN

Quantity affected

9 units

Distribution

USA Nationwide Distribution in the states of NY, NC, DC, FL, PA

Date initiated

2014-04-03

Date posted

2014-04-22

Date terminated

2015-03-18

Location

Fremont, CA