Events

Recall of Device Recall Medtronic Navigation Oarm 02

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
    74158
  • Event Risk Class
    Class 2
  • Event Number
    Z-2083-2016
  • Event Initiated Date
    2016-03-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146536
  • 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
    Review of on-system electronic product labeling and instr uctions for use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21cfr part 1 020.30(h).
  • Action
    Medtronic planned action to bring device into Compliance: 1. You will contact customers and provide an Errata sheet to them updating the missing and incorrect information. 2. Medtronic field service personnel will perform radiation output measurements via validated procedures to attain compliance with 21CRF part 1020.32(k)(6). 3. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For questions call (800)-595-9709.

Device

Device Recall Medtronic Navigation Oarm 02
  • Model / Serial
    model number BT-700-02000
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Medtronic Navigation O-arm 02 surgical x-ray imaging system
  • 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