Events

Recall of Zoll X Series Defibrillators with system software version 02.10.02.00 or higher

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zoll Medical Australia Pty Ltd.

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
    RC-2014-RN-00348-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00348-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Zoll medical corporation has received 8 field reports where the device displayed an internal error reset required message and then entered acontinuous “system reset” loop. the device cannot be used if it is in a continuous system reset loop. zoll medical's investigation has identified a software error associated with the device's “full disclosure log.” the error may occur during specific conditions, and in particular when the full disclosure log reaches its memory capacity (150 cases) due to invalid data in the overwriting of a full disclosure log. the probability of having an event is low under normal operating conditions.
  • Action
    Customers who are having devices with the affected software versions are advised to immediately erase the device full disclosure log per the instructions provided in the customer letters. Users should continue to erase the device log once/month (or before 150 cases are stored in the log) until the device software has been updated. To permanently mitigate the issue, a software upgrade pack will be provided to customers which is anticipated to be available by the week commencing March 24, 2014.

Device

Zoll X Series Defibrillators with system software version 02.10.02.00 or higher

Manufacturer

Zoll Medical Australia Pty Ltd