Events

Recall of Medtronic Navigation Oarm O2 Surgical Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Navigation, Inc.-Littleton.

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
    75279
  • Event Risk Class
    Class 2
  • Event Number
    Z-0070-2017
  • Event Initiated Date
    2016-09-22
  • Event Date Posted
    2016-10-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149921
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    O-arm o2 surgical imaging system spatial calibration may be erroneous in stealth station navigated images.
  • Action
    Medtronic Navigation contacted customers via telephone beginning September 23, 2016. Customers were informed of the affected product, problem and actions to be taken. Medtronic requests that users immediately discontinue the use of the O-Arm O2 Surgical Imaging system for automatic registration in Stealth Station navigated surgical procedures until further notice. Medtronic Service personnel have been scheduled to begin the necessary inspections and re-calibration activities on customer systems beginning on September 23, 2016.

Device

Medtronic Navigation Oarm O2 Surgical Imaging System
  • Model / Serial
    Software revisions 4.0.0, 4.0.1 and 4.0.2. System Serial Numbers: C0930  C0981  C0986  C1113 C1069 C1050 C1208 C1043 C1144 C1163 C1145 C1162 C1002 C1074
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
  • Product Description
    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 || Product Usage: || The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
  • Manufacturer
    Medtronic Navigation, Inc.-Littleton

Manufacturer

Medtronic Navigation, Inc.-Littleton
  • Manufacturer Address
    Medtronic Navigation, Inc.-Littleton, 300 Foster Street, Littleton MA 01460-2017
  • 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
    USFDA