—#126666

Product

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

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
Affected 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.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47215 Lakeview Blvd, Fremont, California 94538-6530

Distribution

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

Timeline

Recall initiated: 2014-04-03
Posted by FDA: 2014-04-22
Terminated: 2015-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126666. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.