Events

Recall of Device Recall OARM(R)

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    45967
  • Event Risk Class
    Class 2
  • Event Number
    Z-0624-2009
  • Event Initiated Date
    2007-11-27
  • Event Date Posted
    2009-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66594
  • 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
    Mobile X-Ray System - Product Code IZL
  • Reason
    Navigation accuracy problem: accuracy may fall outside of specification when used in combination with the medtronic synergy experience stealthstation system spine software with the o-arm intraoperative imaging system and tracker.
  • Action
    Medtronic Navigation notified Field representatives on 11/27/07 to perform site visits to implement FCA 2007-005 - O-Arm Intraoperative Imaging System Accuracy, and deliver the Customer Letter notification. Confirmation of the visit was documented.

Device

Device Recall OARM(R)
  • Model / Serial
    Software versions prior to version 3.0.2 S/N: 102-155
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore
  • Product Description
    Medtronic O-Arm Intraoperative Imaging System || Catalog Number: BI-700-00027
  • Manufacturer
    Medtronic Navigation, Inc

Manufacturer

Medtronic Navigation, Inc
  • Manufacturer Address
    Medtronic Navigation, Inc, 826 Coal Creek Circle, Louisville CO 80027-9710
  • Source
    USFDA