Events

Recall of Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-01266-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01266-1
  • 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
    Following an internal investigation triggered by reports in the field, it was identified that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. in such a situation the inability to defibrillate or a delay in doing so can as a consequence lead to the death or severe injury of the patient. this potential malfunction can occur with these electrodes after a duration of storage of about 2 years or more.
  • Action
    Customers are advised to quarantine affected lot numbers and return for replacement This action has been closed-out on 24/05/2016.

Device

Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
  • Model / Serial
    Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillatorsProduct Codes: 2059144-001 & 2059144-005 (DF69, 50461)Lot numbers: 21003-0770, 21113-0777 & 21220-0771ARTG number: 208134
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd