Device Recall Medtronic Oarm O2 Imaging System

  • Model / Serial
    Serial Number: C0936
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to Austria only.
  • Product Description
    Medtronic 0-arm 02 Imaging System || Catalog Number: Bl-700-02000 || The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. || The O-arm O2 Imaging System is compatible with certain image guided surgery systems.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Navigation, Inc., 300 Foster St, Littleton MA 01460-2017
  • Manufacturer Parent Company (2017)
  • 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
    USFDA