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 Mobile. 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
- Company
- Volcano Corporation
- Recall Initiated
- June 22, 2015
- Posted
- July 20, 2015
- Terminated
- April 14, 2017
- Recall Number
- Z-2133-2015
- Quantity
- A total of 4007 devices, all models
- Firm Location
- Rancho Cordova, CA
Reason for Recall
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
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, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina
Lot / Code Info
Model CORE Mobile. Part number: 400-0100.01.
Root Cause
Software design
Action Taken
Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex.
More recalls by Volcano Corporation
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and...
Dec 12, 2019
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173
Product Usage:...
Oct 17, 2018