Reported Apr 30, 2014 · Terminated
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 47215 Lakeview Blvd · Fremont, CA · 94538-6530
Is this the product you have?
- iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
- Lot codes and dates
- Model NumbersH749ILAB120CART0 H749ILAB120INS0
- H749ILAB120N2710 Serial numbers4219, 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
- Amount recalled
- 9 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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