Recall Z-2136-2015 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corporation
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 CORE Radiology: The 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
| Date | Jul 20, 2015 (initiated Jun 22, 2015) |
| Status | Terminated |
| Reason | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. |
| Root cause | Software design |
| Action | Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex. |
| Quantity | A total of 4007 devices, all models |
| Distribution | Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123898 | VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM Volcano Corporation, Jan 14, 2013 |