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Terminated

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

FDA Recall Z-1487-2014 · Posted 2014-04-22

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeIYN
Date Initiated2014-04-03
Date Terminated2015-03-18
Product Quantity9 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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