Boston Scientific Corporation: Medical Device Recall in 2014 - (Recall #: Z-1487-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 3, 2014

Date Posted: April 30, 2014

Recall Number: Z-1487-2014

Event ID: 67959

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.

Status: Terminated

Product Quantity: 9 units

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated