Events

Recall of Device Recall Life Vest WCD 3000 Electrode Belt

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

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
    25387
  • Event Risk Class
    Class 2
  • Event Number
    Z-0578-03
  • Event Initiated Date
    2003-01-10
  • Event Date Posted
    2003-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25718
  • 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
  • Reason
    Wires may break or pull out, causing device to malfunction.
  • Action
    The recalling firm telephone the end/prescribed users and distributors. Follow up letters were issued to those that received phone calls. The end/prescribed users'' physicians were also notified via letter.

Device

Device Recall Life Vest WCD 3000 Electrode Belt
  • Model / Serial
    Product No 10A0889-A01
  • Distribution
    The device was shipped to distributors, hospitals, sales representatives. End users were prescribed by their physician. Distribution was to: CA, FL, GA, ID, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, UT and WA; and to Spain, Denmark, Italy, Turkey, Germany, United Kingdom, France and Belgium.
  • Product Description
    Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
  • Manufacturer
    Lifecor Inc

Manufacturer

Lifecor Inc
  • Manufacturer Address
    Lifecor Inc, 121 Freeport Rd, Pittsburgh PA 152383447
  • Source
    USFDA