FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2136-2015
- Recalling firm
- Volcano Corporation
- Product
- 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
- Status
- Terminated
- Initiated
- 2015-06-22
- Posted
- 2015-07-20
- Terminated
- 2017-04-14
- 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, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina
- Lot, serial or model codes
- Model CORE. Part number: 400-0100.02.
- 510(k) numbers
- ["K123898"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 2939520
- Firm city
- Rancho Cordova
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28