Events

Recall of Device Recall Zoll E Series Defibrillator with 12 Lead ECG

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
    46408
  • Event Risk Class
    Class 2
  • Event Number
    Z-1167-2008
  • Event Initiated Date
    2008-01-15
  • Event Date Posted
    2008-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67385
  • 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 defibrillator - Product Code MKJ
  • Reason
    Incorrect patient records: patient records that have been stored, then later transmitted or printed may not be the correct record. records that are transmitted or printed immediately following acquisition are correct.
  • Action
    Consignees were notified by an Urgent Device Correction letter sent on 1/14/08. The letter instructed users to complete and return a response form. Upon receipt of the response form, the recalling firm will have sent a software update. The letter also provided instructions for users to follow in order to avoid the software error before the software update was received. For additional information, contact 1-800-348-9011.

Device

Device Recall Zoll E Series Defibrillator with 12 Lead ECG
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Canada, AE, Australia, Belgium, Chile, Germany, Spain, France, UK, Hungary, India, Italy, Jordan, Kuwait, Netherlands, Russia, Saudi Arabia, Singapore and ZA.
  • Product Description
    Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824.
  • 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 01824-4105
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA