Events

Recall of Device Recall Volcano brand Intravascular Ultrasound

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Volcano Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63102
  • Event Risk Class
    Class 2
  • Event Number
    Z-2345-2012
  • Event Initiated Date
    2012-08-24
  • Event Date Posted
    2012-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112549
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    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.
  • Action
    Volcano Corporation sent an "IMPORTANT FIELD CORRECTIVE ACTION" letter dated August 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Volcano sales representative or Volcano Customer Service for questions regarding this recall.

Device

Device Recall Volcano brand Intravascular Ultrasound
  • Model / Serial
    All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    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 histology.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Manufacturer Address
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA