Z-1487-2014Class II

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

Name: Z-1487-2014 iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of...
Creator: Boston Scientific Corporation
Published: 2014-04-03
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-04-03 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology on 2014-04-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1487-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Posted: 2014-04-22
Terminated: 2015-03-18
Recalling firm: Boston Scientific Corporation
Product: iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 9 units
Distribution: USA Nationwide Distribution in the states of NY, NC, DC, FL, PA
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1487-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1487-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-22

Product code IYN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)