Events

Recall of Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during an imaging procedure)

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-2012-RN-00888-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00888-1
  • 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 identified that when the t-handle on the hraim intubation hoop is tightened on some units, it may stop in a vertical position that prevents the crwprecise (crw precision stereotactic frame) and crwasl (crw arc system) from being properly seated on the head ring.
  • Action
    Integra is providing work around instructions to mitigate the issue and will be contacting all users to replace affected screws.

Device

Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during a...
  • Model / Serial
    Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during an imaging procedure) Catalogue Number : HRAIMAll lot numbers ARTG Number: 160533
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd