Events

Recall of Defibrillator PCA wihtin the monitor of the LifeVest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Lifecor 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
    50119
  • Event Risk Class
    Class 2
  • Event Number
    Z-0883-2009
  • Event Initiated Date
    2008-10-21
  • Event Date Posted
    2009-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74773
  • 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
    wearable, defibrillator, automatic, external - Product Code MVK
  • Reason
    The charging circuit will not shut down properly.
  • Action
    Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.

Device

Defibrillator PCA wihtin the monitor of the LifeVest
  • Model / Serial
    model numbers WCD3000 and WCD3100
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide. OUS: Germany, United Kingdom, Italy, and France.
  • Product Description
    Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. || The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
  • Manufacturer
    Zoll Lifecor Corporation

Manufacturer

Zoll Lifecor Corporation
  • Manufacturer Address
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source
    USFDA