Events

Recall of Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences 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-2013-RN-00467-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00467-1
  • 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
    The manufacturer found that if the headphone jack is in use during a surgical procedure with the ocs2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.
  • Action
    Integra is advising users that the device may still be used providing the audio jack is not used. An Integra representative will contact affected customers to arrange for the disabling of the audio jacks and prevent the problem occurring. No reports of this issue have been received from the field.

Device

Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)
  • Model / Serial
    Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)Catalogue number: OCS2All serial numbers affectedARTG number: 150717
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd