Events

Recall of Medtronic O-Arm O2 Surgical Imaging System (a portable, diagnostic, fluoroscopic 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-2016-RN-00966-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00966-1
  • 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
    After investigation of complaints, medtronic has determined that the o-arm o2 system requires updates. 1. certain aspects of the technical information in the instructions for use document require clarification. the information to be updated includes the system’s specification for x-ray filtration strength, leakage technique factors, tube housing cooling curves, technique factor measuring criteria, and air kerma reference location.2. radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply with requirements.3. the x-ray technique factor display accuracy related to ma might not be compliant to the system specifications.Please note that items 1 and 2 do not affect the safety or performance of the system. item 3 does not increase the safety risk of the product to users or patients, but could affect performance related to image quality.
  • Action
    Medtronic is providing users with updated errata sheets with updated the correct information and following this up with an update to the system software that corrects this information in the on-system Instructions for Use. In addition, Medtronic will be performing the appropriate measurements of air kerma rate, as well as testing the x-ray technique factor display accuracy for compliance.

Device

Medtronic O-Arm O2 Surgical Imaging System (a portable, diagnostic, fluoroscopic x-ray system)
  • Model / Serial
    Medtronic O-Arm O2 Surgical Imaging System (a portable, diagnostic, fluoroscopic x-ray system)Model Numbers: B1-700-00027, BI-700-00028ARTG Number: 135566
  • 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