Events

Recall of Device Recall ZOLL E Series Defibrillator/Pacemaker/Monitors

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ZOLL Medical Corporation, World Wide Headquarters.

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
    55115
  • Event Risk Class
    Class 2
  • Event Number
    Z-1547-2010
  • Event Initiated Date
    2010-03-24
  • Event Date Posted
    2010-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89939
  • 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
    Device issued shock advised message but failed to auto-charge the defibrillator.
  • Action
    Zoll Medical Corporation issued an "Urgent Medical Device Correction" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded. For further information, contact Zoll Medical Corporation 24/7 Technical Support at 1-800-348-9011 or 1-978-421-9460.

Device

Device Recall ZOLL E Series Defibrillator/Pacemaker/Monitors
  • Model / Serial
    Software versions 4.XX, 6.XX and 7.0X in the E Series BLS Model.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.
  • Product Description
    ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. || Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
  • Manufacturer
    ZOLL Medical Corporation, World Wide Headquarters

Manufacturer

ZOLL Medical Corporation, World Wide Headquarters
  • Manufacturer Address
    ZOLL Medical Corporation, World Wide Headquarters, 269 Mill Rd, Chelmsford MA 01824
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA