Events

Recall of Device Recall Zoll

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Medical 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
    26590
  • Event Risk Class
    Class 2
  • Event Number
    Z-1000-03
  • Event Initiated Date
    2003-06-23
  • Event Date Posted
    2003-07-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27941
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    Defibrillator may fail to charge or hold its charge above energies of 75 joules.
  • Action
    Zoll Medical issued a letter on 6/25/03 to domestic consignees and 6/26/03 to international consignees on 6/26/03. Letters were issued Certified Mail Return Receipt requested. Instructions are provided for Biomedical to charge device and then dump the charge. A damaged device will fail to charge and issue an error message. Users then are requested to return device. Firm will initiate telephone contact on 6/30/03 to all accounts to verify receipt of notice and confirmation of testing per the instructions.

Device

Device Recall Zoll
  • Model / Serial
    Serial Numbers: T02I37097-T03C45238
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Emirates, Australia, Brussels, Brazil, Canada, China, Columbia, Chezche, Germany, Spain, Finland, France, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, Mexico, Netherlands, Poland,Romania, Saudi Arabia, Syrai, Thailand, Turkey,
  • Product Description
    Zoll M Series External Defibrillator
  • Manufacturer
    Zoll Medical Corporation

Manufacturer

Zoll Medical Corporation
  • Manufacturer Address
    Zoll Medical Corporation, 32 Second Avenue, Burlington MA 01803
  • Source
    USFDA