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

Recall Z-2345-2012 — Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histolog

U.S. FDA — Device Enforcement · United States · 2012-08-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2345-2012
Date of alert: 2012-08-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Volcano Corporation
Product category: device
Product type: Devices

Reported risk: The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.

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.

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