Events

Safety Alert for TBS iNsight

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medimaps.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-11-09
  • Event Date Posted
    2016-11-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161110.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medimaps tbs insight medical device manufacturer, medimaps, has issued a medical device safety alert concerning its tbs insight [software version v.3.0.1]. the manufacturer identified a bug in v.3.0.1 when calculating the fracture-risk-assessment-tool (frax) adjusted for trabecular bone score (tbs). according to the manufacturer, the new version of tbs insight v.3.0.2 is available and will fix the following bugs: frax adjusted for tbs: tbs insight v.3.0.2 provides correct calculation of the frax adjusted for tbs. as a reminder, tbs insight 3.0.1 generated erroneous frax adjusted for tbs values or did not generate tbs report in the following case of vertebrae exclusions: if (l1 & l3) or (l2 & l3) are excluded from the bone mineral density (bmd) analysis, if l1-l4 is not entirely scanned, if only l2 or only l3 are excluded from the bmd analysis, when the “always use l1-l4” or “always use l2-l4” option is activated in tbs insight apex archiving: the tbs pop-up window does not prompt during scans archiving process whatever the type of configuration used for scan detection (dxa database monitoring or folder section]. no need to close scan detector anymore. wording improved in different languages on tbs report. the affected customers are advised that an upgrade to v.3.0.2 has to be done as well as an impact assessment. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 november 2016.

Device

TBS iNsight
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medimaps TBS iNsight
  • Manufacturer
    Medimaps

Manufacturer

Medimaps
  • Source
    DH