Events

Recall of O-Arm 1000 Imaging System (3rd Edition)

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-2018-RN-00093-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00093-1
  • 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
    In july 2017, medtronic navigation rolled out routine sw update 3.2.1. this update is in response to customer complaints and addresses several known software anomalies. the software anomalies were reported to affect system behaviour that include the following issues:• inability to power the system after shutdown• system stays in standalone mode• image reconstruction• system/pendant bootup• dose display/report• gantry motion• network communication• system shutdown• early termination of 3d spinin 3 instances, these software anomalies have resulted in aborting use of the o-arm and reschedule of surgeries after incision.
  • Action
    Medtronic will be in contact with customers to arrange for the software update to be installed.

Device

O-Arm 1000 Imaging System (3rd Edition)
  • Model / Serial
    O-Arm 1000 Imaging System (3rd Edition)ARTG Number: 168216 ((Medtronic Australasia - X-ray system, diagnostic, fluoroscopic, general-purpose, application program software))
  • 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