Events

Recall of Device Recall pcFM Software Kit

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
    60867
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-2012
  • Event Initiated Date
    2010-06-11
  • Event Date Posted
    2012-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106686
  • 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
    ComboMap System pcFM - Product Code IYO
  • Reason
    Internal review of validation of pcmf software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
  • Action
    The firm, Volcano Corporation, sent an "IMPORTANT PRODUCT INFORMATION" letter dated June 17, 2010 to all customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the pcFM Software kit to: Volcano Corporation at 2870 Kilgore Road, Rancho Cordova, CA 95670 and contact (800) 228-4728 for instructions on returning the product. The customers were also instructed to complete and return the attached Customer Reply Letter form to Volcano even if they no longer use the pcFM Software Kit via fax to Volcano Customer Support at (916) 638-8812. If you have any questions, contact your Sales Representative or Customer Service at (800) 228-4728.

Device

Device Recall pcFM Software Kit
  • Model / Serial
    Model 6830 ComboMap Software kit; Kit P/N #'s: 803259001; 806431005; S2000061, 806431002.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, MI, TX, and WI; and countries of: The Netherlands, Sweden and United Kingdom.
  • Product Description
    Volcano pcFM Software Kit ; || Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624. || The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data.
  • 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