Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. |
| Quantity | 9 units |
| Distribution | USA Nationwide Distribution in the states of NY, NC, DC, FL, PA |
| Initiated | 2014-04-03 |
| Classified | 2014-04-22 |
| Terminated | 2015-03-18 |
| Recall number | Z-1487-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-1487-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67959/
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