iLab Ultrasound Imaging System — Class II medical device recall Z-1487-2014
Terminated recall by Boston Scientific Corporation, reported 2014-04-30, distributed nationwide. Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed fro
| Recall number | Z-1487-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Fremont, CA, United States |
| Recall initiated | 2014-04-03 |
| Classified | 2014-04-22 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2015-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 9 units |
| Reason classes | software |
| Serial numbers | 4219, 4900, 5701, 5827, 7516, 7517, 7607, 8407, 8434 |
| Model numbers | H749ILAB120CART0, H749ILAB120INS0, H749ILAB120N2710 |
Product
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1487-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.