Reported Jul 29, 2015 · Terminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout…
Volcano 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: Volcano Corporation · 2870 Kilgore Rd · Rancho Cordova, CA · 95670-6133
Is this the product you have?
- Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits
- Model s5ix/s5iz RadiologyThe Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature
- Lot codes and dates
- Model s5ix/s5iz
- Part number807400-001
- Amount recalled
- A total of 4007 devices, all models
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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