Events

Recall of Zoll X-Series Monitor/Defibrillators

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    16414
  • Event Initiated Date
    2014-03-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Zoll Medical New Zealand, 1st Floor Unit 1, 29 Acheron Drive, CHRISTCHURCH
  • Reason
    Zoll reports that monitor/defibrillator devices operating software version 02.10.02.00 or higher may enter into a continuous system reset loop preventing the device from being used.
  • Action
    Software to be upgraded

Device

Zoll X-Series Monitor/Defibrillators
  • Model / Serial
    Model: , Affected: , Software version: Software Version 02.10.02.00 or higher
  • Manufacturer
    Zoll Medical Corporation

Manufacturer

Zoll Medical Corporation