Events

Recall of Zoll Medical

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
    63004
  • Event Risk Class
    Class 2
  • Event Number
    Z-2401-2012
  • Event Initiated Date
    2012-08-16
  • Event Date Posted
    2012-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112238
  • 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
    Shipped with incorrect software.
  • Action
    Zoll Medical telephoned affected customers on August 16, 2012. Customers were informed of the affected product, problem and actions to be taken. Customers were instructed to remove and return the affected product for replacement. For question contact ZOLL's Technical Support.

Device

Zoll Medical
  • Model / Serial
    Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944  AR12F001100, AR12F001298.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
  • Product Description
    Zoll X Series Defibrillator/Pacemaker/Monitor || Product Usage: || The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).
  • Manufacturer
    ZOLL Medical Corporation

Manufacturer

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