Volcano Corporation: Medical Device Recall in 2015 - (Recall #: Z-2133-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 22, 2015

Date Posted: July 29, 2015

Recall Number: Z-2133-2015

Event ID: 71654

Reason for Recall:

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

Status: Terminated

Product Quantity: A total of 4007 devices, all models

Code Information:

Model CORE Mobile. Part number: 400-0100.01.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated