Events

Recall of Medtronic O-arm O2 Imaging System X-ray system

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medtronic Navigation Inc.

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
    20411
  • Event Initiated Date
    2016-07-26
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Reason
    The o-arm® system requires updates in order to maintain compliance with applicable performance standards. specifically,, 1.Certain aspects of the technical information in the instructions for use document require clarification., 2.Radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply with requirements., 3.The o-arm system x-ray technique factor display accuracy related to ma might not be compliant to the system specifications.
  • Action
    Software to be upgraded

Device

Medtronic O-arm O2 Imaging System X-ray system
  • Model / Serial
    Model: B1-700-02000, B1-700-00027 & B1-700-00028, Affected: , Software version: Software Version 3.1.x, Software Version 3.2
  • Manufacturer
    Medtronic Navigation Inc

Manufacturer

Medtronic Navigation Inc
  • 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
    NZMMDSA