Events

Recall of TBS iNsight Version v.3.0.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medimaps Group.

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
    75510
  • Event Risk Class
    Class 2
  • Event Number
    Z-0369-2017
  • Event Initiated Date
    2016-10-03
  • Event Date Posted
    2016-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150595
  • 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
    Densitometer, bone - Product Code KGI
  • Reason
    The frax adjusted for tbs values are not correct when: the frax feature is activated in tbs insight; and tbs has been computed from a spine scan where some vertebrae were excluded.
  • Action
    Medimaps sent an Urgent Field Safety Notice letter dated October 3, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken.

Device

TBS iNsight Version v.3.0.1
  • Model / Serial
    Version v.3.0.1; Serial # 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, 210440
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.
  • Product Description
    TBS iNsight Version v.3.0.1 || Product Usage: || TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
  • Manufacturer
    Medimaps Group

Manufacturer

Medimaps Group
  • Manufacturer Address
    Medimaps Group, Fongit, Chemin des Aulx 18, Plan-les-Ouates Switzerland
  • Source
    USFDA