Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2134-2015 — 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 s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative

U.S. FDA — Device Enforcement · United States · 2015-06-22 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2134-2015
Date of alert: 2015-06-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Volcano Corporation
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related