Events

Recall of Device Recall BI70000027 0arm 1000 Imaging System Mobile Xray System

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
    49501
  • Event Risk Class
    Class 2
  • Event Number
    Z-2034-2008
  • Event Initiated Date
    2008-06-30
  • Event Date Posted
    2008-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73640
  • 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
    Fluoroscopic Image-Intensified X-Ray System - Product Code JAA
  • Reason
    Failure to of affected units to comply with eer/akr limits due to misinterpretation of the measurement requirements specified in 21 cfr 1020.32 (d) (3) (iii).
  • Action
    Medtronic Navigation notified service engineers to retest units for compliance.

Device

Device Recall BI70000027 0arm 1000 Imaging System Mobile Xray System
  • Model / Serial
    S/N: 102, 125, 127, 129, 130, 134, 137, 147, 157, and 159.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, DC, LA, FL. IN, OH, PA, VA
  • Product Description
    BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System || Generating 2D and 3D images of human anatomy for surgical applications.
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • Manufacturer Address
    Medtronic Navigation, Inc., 300 Foster St, 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