Events

Recall of Medtronic Navigation O-Arm Imaging System (Digital fluoroscopic diagnostic portable x-ray system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia 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-00106-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00106-1
  • 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
    Medtronic has identified a potential failure in the braking system that controls the o-arm gantry’s vertical movement. medtronic's internal investigation identified that the transistor which is part of the motion control box that manages the gantry’s vertical movement, could be exposed to a level of current that would damage it and could cause it to fail. if the transistor fails, the brake that holds the gantry in its vertical position could release, allowing the gantry to rapidly descend.
  • Action
    The manufacturer, Medtronic navigation has identified a correction for this potential failure mode by designing and implementing an improved circuit for the braking system that controls the O-Arm gantry’s vertical movement. Medtronic is advising customers to set the OR table/patient height from the floor as low as possible to reduce the risk of adverse health consequence in the unlikely event of the failure mode occurring in the field until affected systems are implemented with the corrective action.

Device

Medtronic Navigation O-Arm Imaging System (Digital fluoroscopic diagnostic portable x-ray system)
  • Model / Serial
    Medtronic Navigation O-Arm Imaging System (Digital fluoroscopic diagnostic portable x-ray system)Serial Numbers: 101 - 564ARTG Number: 135566
  • Product Classification
    Radiology Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA